A6.0 Attachment 6 - Labor Category Position Description and Key Personnel.pdf

REQUEST FOR PROPOSAL NUMBER

Solicitation Number 47QFWA20K0014

AAS FILE ID07200010

Science Technology and Research Team (START) for the

AIR FORCE MEDICAL SERVICE ENTERPRISE-WIDE

TECHNICAL CLINICAL RESEARCH TEAM (TCRT) I

59th Medical Wing (59 MDW)

Performance Work Statement

(PWS)

PART I – THE SCHEDULE

(Sections A - J)

ATTACHMENT 6

LABOR CATEGORY POSITION DESCRIPTIONS

KEY PERSONNEL

June 12, 2020

This document identifies four (4) Key Personnel:

Bio-Scientific and Statistical Subject Matter Expertise

Clinical Research Nurse (RN I)

Epidemiology Data Analyst

Nurse Practitioner

Behavioral Scientist

Duties & Responsibilities:

Responsible for planning, designing, monitoring, coordinating, analyzing and producing scientific content for social and behavioral studies and regulatory documents needed to support these studies.

Develops, designs, and executes large and complex research projects, reviews progress, analyses data and evaluates results.

Consults with users to refine or adapt social science methodologies to fit research requirements;

collaborates in development of new techniques and instruments

Manages and reviews clinical/social writing of study protocols, statistical analysis and study reports.

Develop human influence/factors products utilizing psychological, social, cultural, human factors’ disciplines, and knowledge of strategic communication and public diplomacy to identify and effectively influence individuals or groups of interest.

Support programmatic planning/plan reviews as needed.

May require occasional weekend and evening hours.

Minimum Qualification and Experience:

Required: Masters’ degree in Social Sciences (psychology, social psychology, behavioral science, and/or cultural anthropology); PhD preferred.

5 years’ minimum experience in human influence experience/social research.

Proven expertise in conducting social science analysis and human influence analysis.

Minimum of 10 years demonstrated experience conducting social research.

Successful completion and maintenance of Human Subjects training (CITI) / training in human subjects' research protection, bioethics, and HIPAA.

Intermediate+ experience with Microsoft Office applications including: Word, Excel, PowerPoint, and Outlook.

Biomedical Engineer

Support Government PIs and research scientists by providing guidance in the engineering aspects of biological systems through design and modeling.

Participate and contribute in experimental design of specific projects requiring computation modeling and simulation of biological mechanisms/systems.

Collaborate closely with multiple teams to coordinate resources such as knowledge and skill sharing across different research projects.

Provide technical support and understating of innovative technological advances in the biomedical field including but limited to novel materials, designs, programs, and approaches.

Prepare and present research findings to internal and external collaborators as well as stakeholders.

Minimum Qualifications and Experience:

Bachelor’s Degree in Biomedical Engineering or related engineering fields.

A minimum of five (5) years of experience in research and development, specifically in areas of physical computational modeling, biomechanics, and systems design.

Biomedical Research Assistant

Responsible for supporting laboratory based research applying the latest scientific knowledge towards the solution of a broad range of theoretical and practical problems in the areas of trauma and clinical care research and integrative clinical medicine.

Implement and maintain research files.

Assist with preparation for presentations and written published articles.

Perform daily laboratory experiments.

Aid in obtaining peer-reviewed manuscripts and composing annotated bibliographies.

Assist in ordering and maintaining inventory of supplies.

Perform daily data analysis and report such to PI and other research staff.

Provide additional functionality incidental to research activities.

Set up, operate and maintain laboratory equipment and apparatus.

Compile and may analyze data using scientific or statistical techniques.

Write and edit material for Standard Operating Procedures.

Report on status of research activities.

Daily handle and restraint of various small and large animal species while assisting with preclinical studies.

Aid in Maintaining sterile equipment, pest control, quality assurance procedures and record keeping.

Aid in conducting daily and weekly inspections or areas of responsibility to ensure compliance with standards.

Aid in coordinating animal procurement and shipping procedures.

Required: B.S in Biological Sciences or a closely related field.

1-3 years of experience in the biological sciences environment.

A minimum of 1-3 years of experience conducting small/large animal surgeries

Proven expertise in working with biological specimens and animal tissue.

Must successfully complete AALAS accreditation training for working with laboratory animals and remain current.

Must successfully complete CITI training and remain current.

Operational knowledge of computational systems (with Microsoft Office) and advanced lab equipment.

Working knowledge of computing equipment to include physiological data acquisition and analysis.

Biomedical Research Associate

Assist with administrative tasks, including preparation and revision of contracts, IACUC and IRB protocols, proposals, manuscripts, report and presentation editing and review.

Ability to coordinate the implementation of clinical research studies, including regulatory requirements, maintenance of study records and all activities associated with internal and external audits.

Assist in ordering and maintaining inventory of supplies.

Aid in drafting contracts for equipment and services.

Initiate and maintain regulatory IACUC/IRB requirements.

Modify and plan research experiment schedules, procedures, and tests.

Ability to research and collect data through complex laboratory/scientific experiments, techniques, and procedures, library research, or through other means for research projects.

Conduct and support surgical procedure, operating room maintenance, animal disease prevention and health surveillance, appropriate animal housing, record keeping, insuring specific pathogen free techniques to include daily handling and restraint of various small and large animal species, as applicable.

Oversees the work of more entry level staff.

Assist with preparation for presentations and written published articles.

Writes and edits material for publication and presentation.

Reports on status of research activities.

Oversees and instructs research and support staff on technical procedures, equipment operation, and laboratory maintenance.

Schedules and coordinates research activities.

B.S. in Biological Sciences or Equivalent level education minimum; Masters preferred.

5 years of relevant experience.

Proven expertise in working with biological specimens and animal tissue.

Must successfully complete AALAS accreditation training i working with laboratory animals and remain current.

Must successfully complete CITI training and remain current.

A minimum of 5 years of experience conducting small/large animal surgeries.

Operational knowledge of advanced lab equipment.

Working knowledge of computing equipment to include physiological data acquisition and analysis.

Bio-Scientific and Statistical Subject Matter Expertise

This position is identified as Key Personnel

Summary:

Develops strategies using statistical analysis to draw scientific conclusions or predications based on data summaries or statistical analysis for Enterprise-Wide research activities. Determines which statistical methodology is applicable based on comprehensive knowledge of parametric and nonparametric hypothesis tests, univariate and multivariate linear and nonlinear modeling, life table analysis, time series analysis and instrument validation procedures. Detailed support shall include:

Development of detailed data and process models.

Proficiency in delineating requirements within the Statistical Package for the Social Sciences (SPSS) and/or Statistical Analysis Software (SAS).

Provide biostatistical consultation to PIs or colleagues. Coordinate database preparation for data analysis, including assessment for any data transformation requirements.

Provide written detailed analysis plans and descriptions of analyses and findings for research protocols or reports.

In-depth analysis of clinical or survey data using statistical approaches including but not limited to longitudinal analysis, mixed effect modeling, logistic regression analysis and model building techniques.

Review clinical or medical research protocols and recommend and conduct appropriate statistical analyses.

Prepare statistical data for inclusion in data monitoring committees, AF/DoD/Federal regulatory agencies, project managers or investigators.

Calculate samples size requirements for clinical studies.

Determine project plans, timelines, or technical objectives for statistical aspects of biological research studies.

Translate statistical information into documents relevant to manuscripts/ presentation being published by investigators. Prepares written synthesis of analysis results for inclusion in research manuscripts, presentations, and reports. Assesses the adequacy of the presentation of data, methods and purported objectives of the research projects.

Master of Science in Statistics required

Minimum of eight (8) years of experience in the field of bio-medical and laboratory management within the last 9 years preferred with experience related to conducting clinical research and analyzing medical data.

Broadcast Technician

• Working knowledge and experience with live broadcast and video streaming (MIST, Military

Interagency Satellite Training). Experience with multi-camera video switchers is essential.

• Broad knowledge of the setup and operation of video/audio conferencing, video streaming, video

IMAG, LCD/DLP projection, flat screen displays, cameras, and recording equipment.

• Demonstrated competency in editing and production of video.

• Check and adhere to production work schedule for job assignments and work reporting times.

• Perform quality control inspections and continuously monitor for acceptable standards.

• Prepare studio and set for broadcasts

• Operate sound and lights in-studio and provides camera-switching to our live-streaming end-users.

• Monitor and troubleshoot stream quality during live production.

• Assist on-air talent, employees, and clients with all things production-related.

• Create multimedia content for classes and for training of remote disease mangers.

• Catalog finished product in a content management database.

• Assist in the coordination of pre-production and production planning activities.

• Work in collaboration with subject matter experts and production staff to produce a variety of video products for satellite broadcasting, DVD distribution, webcasting, and video streaming.

Provides technical support to system users and customer support staff. Evaluates user needs, defines technical problems, and works with engineering/development staff to determine solutions. Assists customer in implementing solutions. Performs ongoing activities to maintain and enhance overall system performance.

Works on projects/matters of limited complexity in a support role.

Minimum Qualification and Experience:

Must have a Bachelor’s degree in Electronic Media, Video Broadcast, or a related field.

Minimum of one (1) year of experience operating Tri-caster technology and certification.

Budget and Financial Management Specialist:

Summary:

Using AFMS enterprise-wide established accounting and financial procedures, provides analysis of fiscal data, and program financial execution and operations. Utilizes fundamental fiscal concepts in preparing written and oral budgetary recommendations for Enterprise-Wide budget requirements. Collaborates with various medical research facilities management staff and other personnel on technical budgetary matters.

Provides general preparation and administration of the various enterprise-wide research budgets, to include short and long range budgetary projections utilizing economic forecasting and financial analytic techniques.

Utilizes current organization-wide and/or resource management specific software to complete assignments.

Duties & Responsibilities:

Deliverables required for enterprise-wide activities:

Provide financial and budget analysis for research project(s).

Provide daily monitoring of project(s) funding.

Provide analytical support for budgetary, administrative, and statistical budget formulation activities.

Perform a wide variety of technical tasks in support of the financial analysis process, including gathering, compiling, and analyzing data from a broad range of sources, using a variety of analytical techniques.

Deliver reports and presentations for colleagues and senior managers.

Must proficiently execute Enterprise-Wide forms and reports listed below:

Military Interdepartmental Purchase Requests (MIPRs)

Funding Authorization Document (FAD) requests

Requests for Load/Change in Fund Target sheets (AF Form 1269)

AF Form 9 (Purchase Request)

Unfunded Requests

Equipment/Supply custodian letters

Budget Execution Report (BER)

Open Documents Listing (ODL)

Selective Transaction History (STH)

Status of Funds (SOF)

Financial plan

Research portfolio

Project status

Tri-Annual Review (TAR)

Market research for labor contracts

Price out gov't/contractor TDYs

Working with PI’s to develop budget requirements for proposal submissions

Revise project budget sheets

Track project spending

Track/log trip reports

Provide data for PMR/QPUR/Synopsis/SITREP

Review proposals for cost effectiveness

All information systems shall have minimum requirements for access consistent with published DoD policies and procedures (DoD Instruction 8500.2). Non Critical–Sensitive requiring an IT Level II designation for all users. (ANACI Secret clearance).

Associates degree Business or in any business related field is required; Bachelor degree is strongly preferred.

A minimum 2 years of experience with Defense Enterprise Accounting and Management System (DEAMS), Commanders Resource Information System (CRIS), Defense Medical Logistics Standard Support (DMLSS), and the Defense Travel System (DTS).

1 year of experience with the Comprehensive Capital Analysis and Review (CCaR).

Clinical Data Analyst

Coordinates database; create user profiles; query system to produce reports; perform data cleaning and quality control; and maintain data dictionary statistics.

Develop and implement empirically sound data analysis plans in keeping with evaluation and research questions.

Perform routine and complex statistical analysis, ensuring statistical integrity and efficiency using statistical software.

Coordinate all data collection and entry activities, ensuring minimum data integrity standards and completion of tasks in a timely manner.

Identify data entry barriers, working with program staff to research and address issues.

Collaborate with staff to implement data entry plans, scheduling and monitoring completion of tasks; recommend strategies for optimizing and integrating data across multiple platforms.

Analyze reports of data duplicates or other errors to provide ongoing appropriate communication with staff.

Generate routine and ad hoc reports, charts and other department presentation materials.

Provide support in efforts to develop new data collection instruments and pilot testing.

Support all other evaluation projects, including support in writing evaluation plans and research proposals and researching grant opportunities.

Update evaluation data; respond to staff requests for data; and conduct routine e-literature search.

Provide support in identifying and interpreting trends and patterns in complex data sets.

Support efforts to conduct surveys and focus groups, and gather other forms of qualitative data, including participant recruitment, volunteer training and scheduling.

Routinely research and provide surveillance accounts of emerging research findings in the field as they relate to key areas.

Master’s degree in a discipline relevant to clinical research, health information science, or other research-oriented disciplines required.

Preferred candidate will have certification from the American Health Information Management Association (AHIMA).

Must successfully complete CITI training and remain current Intermediate+ experience with Microsoft Office applications including: Word, Excel, PowerPoint, and Outlook.

Clinical Molecular Research/Laboratory Technologist

Collaborates with enterprise-wide PIs, in order to develop research protocols that includes human subject research and associated IRB regulatory compliance approvals for the various pilot evaluations to also include animal subjects/ IACUC approvals.

Duties & Responsibilities:

Work as a member of the research team to complete research-related tasks in compliance with federal, DOD and AF research guidelines. Maintain administrative and research records precisely, accurately, and completely; do so in a timely manner.

Collect, transport and prepare samples for laboratory analysis, storage, and/or shipping.

Conduct experimental work and other related duties at the Center for Advanced Molecular Detection or other Joint Base San Antonio laboratories using Government furnished equipment and materials.

Compile and analyze laboratory data, and support other members of the research teams to facilitate success of research work from concept to completion.

Perform duties as needed to further and improve the strategic direction of research projects, consistent with the Chief Scientist's priorities.

Evaluate and disseminate results and findings, with guidance from senior research staff.

Ensure equipment/instrumentation is functioning properly, by performing and documenting quality control procedures.

Conduct operational testing related to diagnosis, treatment, and maintenance of clinical health problems of concern to the warfighter and beneficiaries of military healthcare and aerospace expeditionary operations.

Perform biochemical, cell biological, molecular biological, and other experimental work as needed and required for successful completion of projects.

In a laboratory environment, isolate nucleic acids from specimens/samples received fresh and from samples stored in the laboratory repository. Test and evaluate specimens/samples for amplification of nucleic acids for reverse transcription polymerase chain reaction studies.

Bachelor's degree (Master's preferred) in the biological sciences, (e.g., molecular biology, biochemistry, biology, cell biology, chemistry, microbiology, or related disciplines).

Five (5) years of recent laboratory experience, preferably within the last six (6) years that includes performing various molecular biological and/or protein analysis techniques.

The candidate shall be familiar with medical terminology, to include common medical and scientific abbreviations, and have knowledge of commonly used concepts, practices, and procedures within field of study.

Recommended candidate is certified as a Medical Laboratory Technologist by the American Society of Clinical Pathology or National Certifying Agency.

Clinical Research Assistant

Serves as a Clinical Research Assistant. Exercising the full domain of human subject and animal research, supporting protocol implementation, data collection, human subject and /or animal protection and dissemination of clinical research findings. Prepares protocol binders (manual of procedures), individual subject files/records, assists with human subject informed consent, subject preparation and safety pre, intra and post intervention, experimental work as necessary. Provide clerical support to the primary investigator, project coordinator such as memorandums and reports. Assists with scheduling and administering subject/participant assessments and or interventions. Assists with scheduling meetings, including arranging for space, notifying participants, preparing the agenda and minutes and following-up on all commitments to ensure that necessary arrangements have been made. Must also input research data into several electronic databases which might include: Microsoft Outlook, Excel, WORD, PowerPoint, Access and other databases. Develop spreadsheets and accurately enter study participants' comprehensive assessment data. Research areas include trauma, critical care, en route care, behavioral health, nursing clinical care, precision medicine and more.

Assists primary investigator in planning, managing, and accomplishing research projects or studies in one or more of the above clinical areas.

Coordinates with other study staff (research coordinator, PI, AI), medical treatment facility personnel (surgeon, physicians, nurses, medical technicians, allied health professionals) other departmental technicians, vendors, laboratory personnel as necessary.

Contributes to the development of new clinical research protocols. Assists with research subject/participant informed consent and preparation. Develops comprehensive study files maintaining electronic and hardcopy study files in accordance regulation and policies (HRPO, FDA, IRB). Maintains and organized and secure study file system

Performs verification and validation of study tasks performed including point of care testing, setting up simulation cases, collecting output data, processing and analyzing results, writing up analyses, and preparing presentations about the results and work performed.

Supports experimental work and acquires data as required.

While on duty in the laboratories or medical treatment facility, incumbent is responsible for safety issues related to the equipment in use. This includes that associated with equipment, medications, chemicals, etc., as required by the study protocol.

Maintains control records and follow-up measures on incoming correspondence and action documents to ensure prompt handling.

Participates in program planning support work such as research project coordination, travel documentation, budget coordination/tracking, agreements, and purchasing/procurement of supplies and equipment, and human resources administration.

Advises on procedural and documentation requirements for the current Research Projects, research plans, annual progress reports, international travel proposals and follow-up trip reports, and cooperative agreements, grants, and trusts.

Uses available software systems, specifically which includes the current accounts tracking systems, publication submissions, purchase orders, credit card purchases, and preparation of forms for incoming and out coming funds.

Creates, copies, edits, stores, retrieves, and prints a variety of correspondence and documents (letters, minutes, memos, reports, calendar, etc.), from handwritten drafts into final copy.

Draft letters of response and minutes from meetings.

Screens all outgoing project correspondence for conformance with regulations and station policy, including spelling, grammar, capitalization, punctuation and format.

Alerts staff, particularly the Research Coordinator or PI, when a problem is anticipated, to minimize its effects.

Ensures timely accomplishment of the assigned work.

Maintains files for the program in both paper and electronic format, and ensures that files are backed up, updated and purged appropriately.

Performs periodic inventory of program specific equipment such as medical devices, computers and printers, and keeps the research coordinator and or PI advised of any changes and assists staff in preparing requests for new or replacement equipment.

Maintains appointment schedules for study staff; including setting up meetings, conferences, room reservations, assembling files, and information prior to meetings, and coordinates all travel arrangements, if needed.

Responsible for protecting sensitive data from unauthorized use or deletion and following applicable regulations and instructions regarding access to computerized files and release of access codes, as established in the computer access agreement.

Exercises discretion and confidentiality in handling all human subject/ research participant or animal research related issues.

Associates degree Required, Bachelor’s degree preferred.

Intermediate+ experience with Microsoft Office applications including: Word, Excel, PowerPoint, and Outlook.

Exhibit excellent communication skills in writing, communicating via email, Skype, face-to- face, or phone with study team members and participants of the research project.

Must be able to compose, format and edit memorandums and/or correspondence for grammatical errors for submission of timely and accurate progress reports for the project.

Possess good organizational skills to maintain the project records and files necessary to administer daily operations to include research protocol documents, recruitment applications, informed consents and other administrative documents.

Clinical Research Coordinator

Supports Government directors, PIs, in the planning, programming, and execution of clinical research projects and protocols and associated activities.

Maintains study records in accordance with protocols, study schedules, participant observations, and provides follow up documentation to the PI.

For human research studies, assists with study enrollment and activities related to the conduct of the study.

Coordinates one (1) to several simultaneous projects for the PI/director; confers with investigator on experimental design; provides instruction on various research laboratory techniques, and study participant contact procedures.

Organizes research information; manages reporting and data collection.

Monitors research study budget.

Research equipment/supply catalogs, and recommend purchase requests for projects/protocols in accordance with the IRB.

Documents all regulatory research and administrative actions to ensure study compliance.

Prepares/delivers required reports and other research documentation to PI.

Prepares correspondence, builds study files, develop schedules, and presentation graphics to support the research study.

Uses available software systems, specifically which includes the current accounts tracking systems, publication submissions, purchase orders, credit card purchases, and preparation of forms for incoming and out coming funds.

Required: B.S in Biological Sciences or a closely related field; Masters highly preferred.

2-4 years’ minimum experience in clinical research.

Demonstrate competence in oral and written communication.

Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor.

Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software.

Knowledge of CFR, GCP and ICH guidelines.

Must successfully complete CITI training and remain current.

Completed GCP training and familiar with GCP in practice.

Demonstrated FDA regulatory experience.

Clinical Research Coordinator (CIRS)

Assists the PIs to refine the specific aim, questions, hypotheses, and/or objectives of the research protocols. Assists in ordering study materials, equipment, and/or research animals as specified in the research protocol and in accordance with Clinical Research Division policies.

Conducts the study in accordance with the approved protocol.

Designs a randomization scheme if required for the study. Designs recruitment materials, advertises the study, and recruits participants. Designs measurement schedule and maintains a master calendar for the study and serves as a point of contact for research subjects.

Meets with potential research subjects to explain the research project in detail and enroll eligible subjects into the study by obtaining written informed consent.

Schedules subjects for a research appointment(s) or schedules operating room time as determined by the protocol. Screens patients, patient records, and databases to determine study eligibility and participation using advanced professional skills acquired through nursing training and experience.

Coordinates patient treatment and monitors’ patient response to protocol treatment in clinical trials and communicates results to the PI appropriately. Collects lab samples including blood draws and performs preparation of specimens as required by the protocol.

Administers surveys or questionnaires as specified by the protocol.

Abstracts required research data elements from paper, electronic patient records or other existing documents, clinical computer databases such as the Armed Forces Longitudinal Technology

Application (AHLTA), Composite Health Care System (CHCS) or Joint Patient Tracking Application

(JPTA), and/or electronic diagnostic reports in accordance with the research protocol and enter these data into spreadsheets, databases, and/or statistic software.

Delivers specimens to internal laboratory and/or ship specimens to a referral laboratory as specified by the protocol.

Works with the designated statistician to clean and prepare data sets for analyses.

Collects, sorts, files, and maintains all paper and electronic documents related to the protocol as required by the IRB, IACUC and principle investigator. Submits protocol amendments of the study protocol to IRB and IACUC. Backs up all electronic files regularly. Immediately reports any adverse events to the Medical Monitor or Data Safety Monitoring Board, sponsor, and IRB or

IACUC. Assists the PI to write the final report and submit it to the IRB, IACUC, and study sponsor.

Submits progress reports to study sponsors and appropriate compliance committees as required by local policies and the protocol. Identifies delays and other shortcomings in meeting objective and develop a contingency plan as required.

Maintains complete and accurate drug and equipment accountability at all times for the study.

Communicates and provides information during any sponsor COR site visit related to the study.

Tracks animal use according to protocol requirements.

Prepares documentation for the acquisition of equipment and supplies to meet clinical investigation protocol requirements.

Ensures all members engage and supporting research have adequate safety and regulatory training to meet protocol requirements.

Minimum Qualification and Experience:

Minimum of Bachelor’s Degree in a health related field (i.e., Registered Nurse (RN), Physician

Assistant (PA), Pharmacist, Biologist, Health Scientist, or Public Health Specialist).

Minimum of (3) years of experience as a Clinical Research Coordinator. Experience as an RN or

PA may be substituted for this requirement.

Must complete the Collaborative Institutional Training Initiative (CITI) training prior to starting work and must maintain currency at all times.

The Contractor Personnel shall have and maintain a current Basic Life Support (BLS) certification.

Clinical Research Director Assistant

Assists in institutional research for the 59th Medical Wing.

Assists in operations of the IRB and preparing protocols to go through the board process.

Works with investigators in preparing and reviewing protocols ensuring protocols meet all applicable Air Force, DoD, and Federal requirements.

Manages data collection and analysis and oversees the formulation of research reports (i.e., reports to higher headquarters, accrediting agencies, research partners, etc.)

Assists presiding member of the Wilford Hall Medical Center IRB to develop processes to review and coordinate all research protocols in accordance with the Common Rule, Belmont Report, and other federal, DoD and AF regulations. Assists in developing and writing operating instructions for all processes associated with performing research within the institutions. Acts as an appointed non-voting member of the IRB.

Determines category of IRB approval required for studies submitted.

Assists in preparing IRB agenda working with the IRB Presiding Member and IRB protocol staff and publishes agenda.

Assists in tracking all ongoing approval and concurrence actions from Higher Headquarters and coordinates actions with principle investigators, IRB members, and Division personnel.

Assists in controlling protocol documentation, establishing suspense’s and ensuring documentation is complete and prepared for scheduled IRB meetings.

Assists in completion and review of IRB minutes, reviewing for completeness and thoroughness prior to submission for signature and coordination with higher headquarters review. Assists in ensuring minutes contain all pertinent information relevant to risk determination and regulatory compliance to expedite review by outside compliance agencies.

Assists in tracking training and compliance issues of all individual investigators involved in research in the 59th Medical Wing, ensuring appropriate training is completed as required and that all personnel meet compliance regulations pertaining to research being conducted within the control of the WHMC IRB.

Assists IRB Chair and Presiding Official in conducting meetings ensuring required members are available, votes are cast and conflict of interest issues are resolved in accordance with commonly accepted rules of order.

Reviews protocol changes submitted to fulfill IRB required changes and assists in approval and concurrence actions from the Air Force Surgeon General’s office.

Bachelor of Science Degree with 5+ years of experience in clinical research or a Master’s/PhD in scientific field with 2+years.

Documented authorship of scientific publications, conducting clinical research to include experience in developing and designing research protocols or experience with research compliance and auditing is required.

Experience and broad knowledge of medical, nursing or allied health care fields used to interpret research functions.

Working general knowledge of various medical specialties to thoroughly understand the primary ideas/intent outlined in protocol documents and is able to identify and recommend modifications to correct issues or inconsistencies.

Experience or knowledge of research methodology and experimental design to ensure that protocols are properly developed to meet all compliance guidelines.

Experience and ability to clearly articulate objectives, recommendations and decision, to prepare and present materials and other literature designed for the research process.

Effective interpersonal relation skills to diplomatically deal with novice and seasoned researchers in a number of medical specialties.

Ability to assist in the planning, organizing and administering a variety of programs and activities related to research protocols.

Recent knowledge (within 5 years) of research compliance guidance as outlined in the Office of

Human Research Protection (OHRP) and Office of Laboratory Animal Welfare (OLAW) policies and regulations. Knowledge of DoD or AF guidance and regulations or 3 years of actual research experience can substitute for OHRP and OLAW experience.

The Contractor Personnel shall have and maintain a current Basic Life Support (BLS) certification.

Clinical Research Laboratory Scientist

Be experienced and qualified to do research testing in various fields of Laboratory Science to include but not limited to toxicology, chemistry, microbiology, hematology/coagulation, cell biology, and molecular biology.

Familiarity with solid phase and liquid extractions; gas chromatography, liquid chromatography and mass spectrometry.

Develop methods related to their particular field of expertise to support research protocols approved by regulatory oversight committees. Methods must be developed to meet researchers need and be in compliance with Good Laboratory Practice Guidelines.

Be able to develop test methods and implement testing independently.

Perform manual and automated testing on multiple body fluids from human research subjects and various species of animal subjects as described in approved research protocols.

Perform all required setup and quality control and quality assurance processes required for equipment used in analyzing specimens for research purposes.

Meet all accreditation requirements for Good Laboratory Practices in using manual and automated testing equipment.

Analyze the results of tests and experiments to ensure conformity to specifications, using special mechanical and electrical devices.

Review results of tests and quality control materials to ensure that testing processes were in control and all data produced is accurate and precise.

Analyze and record test data to issue reports that use charts, graphs and narratives.

Able to accurately enter data into various computer systems to meet research protocol requirements and follows established procedures in validating and verifying data entered in to computer systems.

Use standard laboratory techniques and follow operating instructions in preparing materials for test procedures (i.e., standards, calibrators, solutions, and reagents).

Use standard laboratory procedures to prepare specimens for chemical or toxicological analysis.

Process and ship all samples according to regulations and protocol requirements

Document all correspondence and communication pertinent to the research

Assist in the preparation and analysis of laboratory experiments, as requested

Maintain and update files of all applicable regulatory documentation for Institutional Animal Care and Use Committee (IACUC) or Institutional Review Board (IRB) to include protocols, approvals, amendments, modifications, etc., as well as any communications with the sponsor or any other

Federal or regulatory office (including prior approvals, change in scope, etc.

Manage study documentation to include accurate and timely filing

Adheres to Occupational Safety and Health Administration (OSHA), Clinical Laboratory

Improvement Amendments (CLIA), International Air Transport Association (IATA), Good

Laboratory Practices (GLP) and infection control procedures.

Assist in writing method validations, operating procedures, presentations, and publications using provided methodologies and formats.

Collect and process specimens from research subjects for testing purposes. All specimens must be collected, processed and handled as described in approved research protocols.

Assists the PI to refine the specific laboratory requirements to meet the aims, research questions, hypotheses, and/or objectives of the studies.

Conducts laboratory procedures and testing in accordance with the approved protocol. Performs appropriate study specific procedures as outlined in the protocol.

Orders study materials, equipment, and/or supplies as specified in the research protocol and in accordance with Clinical Research Division (CRD) policies.

Maintains all protocol binder to include all approved protocols and amendments and all data obtained from laboratory procedures.

Abstracts required research data elements from paper or electronic systems or other existing documents, clinical computer databases such as the AHLTA, CHCS or JPTA, and/or other electronic diagnostic reports in accordance with the research protocol and enter these data into spreadsheets, databases, and/or statistic software as required.

Delivers and receives specimens to internal laboratory and/or ship specimens to a referral laboratory as specified by the protocol.

Works with the statistician to clean and prepare data sets for analyses.

Collects, sorts, files, and maintains all paper and electronic documents related to the protocol.

Evaluates proposed amendments of the study to identify any changes in laboratory testing requirements as approved by the IRB and/or IACUC.

Maintains complete and accurate drug and equipment accountability at all times for the study.

Identifies delays and other shortcomings in meeting objective and develops a contingency plan as required.

Communicates and provides information during any sponsored Contracting Officer Representative

(COR) site visit related to the study.

Assists the PIs to write the final report and submit it to the IRB, IACUC, and study sponsor.

Manages all aspects of laboratory experiments while in constant communication with the PIs and

CRD leadership.

Actively seeks to learn new laboratory techniques to support new protocol requirements. Manages all laboratory testing requirements to support translational and clinical research projects in concert with the PI.

Arranges learning schedules for Graduate Medical Education (GME) personnel working in the clinical and translational research programs.

Shall have a Bachelor’s degree in a scientific discipline in laboratory sciences or Bachelor’s degree in science-related field with at least 10 years of experience managing laboratory research programs. Master’s degree in basic/laboratory science strongly preferred.

Proven expertise in working with biological specimens and animal tissue ; at least (10) years of experience in research laboratory procedures including but not limited to research specimens from various species, experience using basic and advance laboratory instrumentation, using various testing techniques to determine biological activity, metabolic changes, or biology products, experience in the collection and processing of various biological samples for frozen long term storage and the procedures to recover samples from long term storage for analysis.

Experience or knowledge in performing translational biomedical research, and working in a laboratory performing various techniques to include but not limited to: Flow Cytometry, research involving the use of specimens, PCR/rtPCR testing, expertise in the use and enzyme immunoassay testing assays, use of laboratory equipment including imaging systems, chemistry equipment (i.e., HPLC, GS-MS, etc.), hematology and clinical chemistry analyzers, coagulation testing, experience in cell culture techniques, and extensive experience in collecting processing and archiving specimens for use in translational biomedical research.

Shall have and maintain a current Basic Life Support (BLS) certification.

Intermediate+ experience with Microsoft Office applications including: Word, Excel, PowerPoint, and Outlook.

Must successfully complete AALAS accreditation training for working with laboratory animals and remain current

IATA training must be successfully completed within 6 months of hire

Must successfully complete CITI training and remain current

A minimum of 5 years of experience with increased responsibilities that are directly related to the assigned biological laboratory and/or conducting small/large animal surgeries and/or coordinating laboratory needs including scheduling, supplies and personnel for surgeries.

A minimum of 2 years’ experience leading and/or supervising laboratory personnel and activities.

Operational knowledge of advanced lab equipment.

Clinical Research Molecular Scientist

Be experienced and qualified to do research testing in the field of Molecular Laboratory Science to include but not limited to nucleic acid extraction and quantification, electrophoresis, PCR, rtPCR, Microarray, and Sequencing. Familiarity with various Sequencing techniques to include Pyro- Sequencing, Sanger Sequencing and Next Generation Sequencing (NGS). Experience with multiple library preparation techniques for transcriptome, exome and whole genome NGS.

Develop methods related to their particular field of expertise to support research protocols approved by regulatory oversight committees. Methods must be developed to meet researchers need and be in compliance with Good Laboratory Practice Guidelines. Be able to develop test methods and implement testing independently.

Perform manual and automated testing on multiple body fluids from human research subjects and various species of animal subjects as described in approved research protocols.

Perform all required setup and quality control and quality assurance processes required for equipment used in analyzing specimens for research purposes. Meet all accreditation requirements for Good Laboratory Practices in using manual and automated testing equipment.

Analyze the results of tests and experiments to ensure conformity to specifications, using special mechanical and electrical devices.

Review results of tests and quality control materials to ensure that testing processes were in control and all data produced is accurate and precise.

Analyze and record test data to issue reports that use charts, graphs and narratives.

Enter data into various computer systems to meet research protocol requirements. Follow established procedures in validating and verifying data entered in to computer systems.

Use standard laboratory techniques and follow operating instructions in preparing materials for test procedures (i.e., standards, calibrators, solutions, and reagents). Use standard laboratory procedures to prepare specimens for molecular, chemical or toxicological analysis.

Process and ship all samples according to regulations and protocol requirements.

Document all correspondence and communication pertinent to the research.

Assist in the preparation and analysis of laboratory experiments, as requested.

Maintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.).

Manage study documentation to include accurate and timely filing.

Adheres to Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), International Air Transport Association (IATA), Good Laboratory Practices (GLP) and infection control procedures.

Assist in writing method validations, operating procedures, presentations, and publications using provided methodologies and formats.

Collect and process specimens from research subjects for testing purposes. All specimens must be collected, processed and handled as described in approved research protocols.

Assists the PI to refine the specific laboratory requirements to meet the aims, research questions, hypotheses, and/or objectives of the studies.

Conducts laboratory procedures and testing in accordance with the approved protocol. Performs appropriate study specific procedures as outlined in the protocol. Orders study materials, equipment, and/or supplies as specified in the research protocol and in accordance with Clinical Research Division (CRD) policies.

Maintains all protocol binder to include all approved protocols and amendments and all data obtained from laboratory procedures.

Abstracts required research data elements from paper or electronic systems or other existing documents, clinical computer databases such as the AHLTA, CHCS or JPTA, and/or other electronic diagnostic reports in accordance with the research protocol and enter these data into spreadsheets, databases, and/or statistic software as required.

Delivers and receives specimens to internal laboratory and/or ship specimens to a referral laboratory as specified by the protocol.

Works with the statistician to clean and prepare data sets for analyses.

Collects, sorts, files, and maintains all paper and electronic documents related to the protocol.

Evaluates proposed amendments of the study to identify any changes in laboratory testing requirements as approved by the IRB, Institutional IACUC.

Maintains complete and accurate drug and equipment accountability at all times for the study.

Identifies delays and other shortcomings in meeting objective and develops a contingency plan as required.

Communicates and provides information during any sponsored Contracting Officer Representative (COR) site visit related to the study.

Assists the PIs to write the final report and submit it to the IRB, IACUC, and study sponsor.

Manages all aspects of laboratory experiments while in constant communication with the PIs and CRD leadership.

Actively seeks to learn new laboratory techniques to support new protocol requirements. Manages all laboratory testing requirements to support translational and clinical research projects in concert with the PI.

Arranges learning schedules for Graduate Medical Education (GME) personnel working in the clinical and translational research programs.

Master’s Degree in Molecular Biology or science-related degree with 2+ years’ experience or minimum of Bachelor’s Degree in Molecular Biology with 5 years of recent experience in a molecular biology laboratory.

Shall have at least 5 years of experience in advanced Molecular Laboratory procedures and experience research laboratory procedures including but not limited to research specimens from various species, experience using basic and advance laboratory instrumentation, using various testing techniques to determine biological activity, metabolic changes, or biology products, experience in the collection and processing of various biological samples for frozen long term storage and the procedures to recover samples from long term storage for analysis.

Experience or knowledge in performing translational biomedical research, and working in a laboratory performing various techniques to include but not limited to: flow Cytometry, research involving the use of specimens, PCR/rtPCR testing, expertise in the use and enzyme immunoassay testing assays, use of laboratory equipment including imaging systems, chemistry equipment (i.e., HPLC, GS-MS, etc.), hematology and clinical chemistry analyzers, coagulation testing, experience in cell culture techniques, and extensive experience in collecting processing and archiving specimens for use in translational biomedical research.

The Contractor Personnel shall have and maintain a current Basic Life Support (BLS) certification.

Clinical Research Nurse (LVN)

Manages all areas of clinical studies, including protocol development, regulatory submissions, and data management, specifically preparing protocol submissions, informed consent forms, annual reports, and study amendments for appropriate IRBs of record and provide documentation submissions in accordance with federal and local regulations.

Develops and maintains study source documents and Case Report Forms, prepare study timelines, and when necessary, report adverse events to the appropriate…