B08-Attachment 1 - Labor Category Descriptions 3_24_2023 (Final).docx

Attachment 1 [Version 032423]

TRAVIS AFB – CLINICAL RESEARCH SUPPORT SERVICES

Labor Category Descriptions

This attachment covers the following: (1) processes to be performed in support of the mission of the Clinical Investigation Program (CIP); and (2) qualifications for personnel performing to this attachment.

A. PROCESSES

1. Clinical Research Nurse (1 FTEs)

Specific tasks include:

a. The Clinical Research Nurse will be able to function as a Clinical Research Coordinator and shall assist primary investigators with the following tasks in order to develop institutionally‐approved research protocols:

1) Identify the appropriate forms and processes necessary to complete the research protocol.

2) Refine the specific aims, research question hypothesis and/or objectives of the proposed study.

3) Coordinate statistical and scientific consultation from CIF staff.

4) Develop an individualized timeline for each protocol.

5) Complete the necessary documents for approval, including the informed consent, recruitment materials, and data collection forms.

6) Coordinate administrative, IRB, and/or IACUC (Institutional Animal Care and Use Committee) approval of proposed research protocols.

7) Must Obtain and maintain NIH and CITI training in accordance with local IRB policy.

b. Organize and prioritize all activities associated with conducting phase I, II and III clinical trials and clinical studies within a military setting.

c. Review and understand biomedical research protocols, ensuring applicable regulations and guidelines are followed.

d. Develop source documents for assigned studies, manage data collection, and ensure all Adverse Events (AEs) are identified and reported appropriately.

e. Enter required data on paper or electronic case report forms (CRFs), audit records for accuracy, resolve discrepancies, and correct as necessary.

f. Collect, organize and maintain all essential documents required for study regulatory files.

g. Coordinate with external monitors and internal quality assurance to assure compliance with protocol, Standard Operating Procedures (SOPs), regulations and guidelines.

h. Conduct protocol evaluation and feasibility assessment of proposed clinical research.

i. Prepare relevant documentation for submission to the Institutional Review Board (IRB).

j. Develop patient information and informed consent forms and patient recruitment materials.

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

l. Communicate with the IRB point of contact (POC); as required, in order to maintain protocol renewals and meet any and all interim reporting requirements.

m. Provide internal assessment of adherence to approved protocols, as well as all relevant DoD and FDA regulations, under guidance of the Principle Investigator (PI).

n. Obtain and maintain NIH and CITI training in accordance with local IRB policy.

o. Support the oversight of the CIF’s quality assurance program to ensure compliance with applicable rules and regulations in support of new and ongoing clinical trials and other clinical research activities.

p. Develop clinical quality management plans and materials to support the CIF research program.

q. Review and assess existing clinical quality assurance efforts.

r. Assess adherence to protocols, as well as relevant Air Force, DoD and FDA regulations and guidance.

s. Complete routine audits of clinical study documentation and procedures to ensure adherence to above.

t. Identify areas of deviation from protocols, ethical standards, regulations and or guidance, and recommend corrective actions.

u. Document resolution of findings, analyze data and report non‐compliance to appropriate individuals.

v. Secondary Activities

1) Develop and implement SOPs as or where necessary.

2) Prepare research oversight and compliance documents and tools for assessment, as or where necessary.

3) Serve as the liaison between study sponsors, investigators, departmental research personnel and other individuals assigned to the study.

4) Independently develop training materials and conduct education of physician and nursing staff on specifics of the research protocol, study design, investigational therapeutic agents, procedures and/or techniques specific to the assigned study.

5) Perform patient education regarding study participation, outlining protocol and time table of patient requirements.

6) Coordinate the activities of research personnel to ensure quality patient care and adherence to research GCP principles.

7) Focus on the care of research study patients with regard to each study's safety considerations.

8) Work with multidisciplinary teams providing and directing nursing care in a research environment.

9) Draw on nursing experience and utilize advanced assessment skills to identify patient care problems, formulate patient care plans and continually revise plans to adjust to changes in complex and unstable patients under routine and emergent conditions.

10) Develop and implement SOPs, compliance documentation, and tools for assessment.

11) Assist with the administration of procedures related to the development, implementation, management, evaluation, and continuous quality improvement of organizational operations.

12) Support and maintain quality corrective action/preventative action system.

13) Manage the CIF’s document control system; prepare documents for review and signature, maintain a tracking system for status of SOPs and SSPs, issue SOPs/SSPs both electronically and hard copy, distribute revisions as required.

14) Support and maintain clinical study regulatory readiness and actively participate in regulatory inspections. May serve as audit host for regulatory inspections for the 60th MDG CIF program.

15) Develop and deliver training in quality assurance/quality control for clinical studies as necessary. Provide for methods to assess competency and maintain supporting documentation.

2. Chief, Research Oversight, and Compliance (1 FTE) … No Inherently Government Functions

Specific tasks include:

a. The Chief, Research Oversight, Compliance (Chief, ROC) will provide oversight and guidance to the human protection and animal welfare programs at the Clinical Investigations Facility. Work is completed in accordance with the processes and procedures that ensure compliance with federal and state regulations and institutional policies relative to research at the Clinical Investigations Facility, 60th Medical Group. The Chief, ROC will serve as the principal communications advisor to the Clinical Investigations Director on all collaborative research development. The Chief, ROC will be responsible for coordinating diverse outreach activities that involve facilitating collaborations between Principal Investigators (PIs), Resident Researchers and Faculty with, other government agencies, industry, academia and other related research organizations. In addition, the Chief, ROC will advise, draft and coordinate collaborative agreements, ensure Air Force Intellectual Property Rights are protected, and file invention disclosures as needed.

b. The Chief, ROC shall perform the following primary Institutional Review Board (IRB) functions in support of research protocols:

1) Review new research applications in support of human model clinical investigations/research and other related research requirements to help ensure consistency, completeness, and compliance with federal and state regulations as well as institutional guidelines prior to IRB review. Work with Principal Investigators (PIs) to ensure that research applications are complete. Communicate to PIs items requiring clarification, or documents required for submission, prior to IRB review.

2) Review all complete project submissions, determine review type, recommend assignment for reviewers, and recommend exempt status.

3) Review Informed Consent Documents (ICDs) for protocol and amendment‐specific content and help ensure presence of federally mandated elements of informed consent.

4) Provide written correspondence to PIs communicating the outcome of the research application by the IRB. Note: the IRB is comprised of Government representatives.

5) Provide support as in‐house advisor to administration and researchers for DoDI 3216.02

6) Perform initial and adjunct ethics and legal reviews of research applications for exempt and non‐exempt review.

7) Support initial legal review of site specific CRADAs and invention disclosures.

8) Support preparation of Institutional Animal Care and Use Committee (IACUC) agendas, meeting minutes and other animal protection‐related duties as required.

9) Support ongoing compliance and management of program audits of sponsored research programs.

10) Evaluate reports of unanticipated problems, protocol amendments and continuing review forms, and prepare recommendations to the IRB committee.

11) Report serious non‐compliance issues to the IRB Director (a Government representative).

c. Perform the following IRB administrative duties in support of IRB operations:

1) Coordinate a team approach to produce the monthly IRB agenda for each meeting and help ensure that materials are distributed within established guidelines.

2) Work with other members of the team, attend IRB meetings, record deliberations, document meeting minutes for IRB Chair approval.

3) Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions.

4) Assist with training and orientation tasks of new committee members.

5) Provide direct guidance (but not supervision), and serve as a resource, to coworkers in the IRB office.

6) Monitor the regulatory environment and recommend changes, as needed, to institutional officials.

d. Provide guidance and oversight of an electronic IRB system (eIRB).

1) Coordinate appropriate training to implement and maintain eIRB.

2) Manage the day‐to‐day maintenance of eIRB.

3) Facilitate uploading all appropriate documents and files to eIRB.

e. Support and coordinate internal and external audits of all human research projects.

1) Provide guidance and direction for any internal audits of human research studies to ensure all appropriate regulations are followed

2) Coordinate and support any external audits of human research projects

3) Facilitate periodic audits of all IRB‐approved research studies, and ensure findings are appropriately documented and any deficiencies adequately addressed.

f. Interact with DGMC project personnel to include investigators, residents, faculty, affiliated scientists, external committee members, etc. and contribute to strategies to bridge capabilities with DGMC researchers and external collaborators.

1) Draft, edit and track research collaborative agreements to include: CRADAs, Material Transfer Agreements, Non‐Disclosure Agreements, MOUs, MOAs, Work Plans, Patent Licensing Agreement, Interagency Agreements, Invention Disclosures, etc.

2) Review research plans and collaborative agreements for potential intellectual property rights and invention disclosures. Ensure proper documentation and submission of appropriate disclosures to protect the rights of the Air Force and its collaborators.

3) Ensure all required communications, reports and agreements are submitted and approved through the proper chain of command.

g. Perform the following additional functions, as needed, in support of Clinical Investigation Facility operations.

1) Maintain collaborative team relationships with peers, colleagues and customers in order to effectively contribute to the working group’s achievement of goals and help to foster a positive work environment.

2) Attend seminars, workshops and conferences (as budget will allow) in order to gain insight into new trends in human and animal research and to learn new approaches for the application of federal regulations, particularly in an atmosphere of increasingly sophisticated technology.

3) Participate in, or present at, research‐related education sessions.

4) Work collaboratively with the IRB Chair to facilitate ongoing development, implementation and maintenance of the human subject’s protection program.

5) Assist in preparing Institutional Animal Care and Use Committee (IACUC) agendas, meeting minutes and other related duties as required.

3. Biostatistician (1 FTE)

Specific tasks include:

a. The Biostatistician will provide statistical services and support compatible with the Clinical Investigations Facility 60th MDG operating capacity and equipment.

b. The Biostatistician shall provide expert guidance to primary investigators on appropriate experimental design:

1) Consult with primary investigators to refine research design and analytic plan.

2) Review proposed research protocols to ensure adequate sample size and statistical analysis.

3) Provide input and guidance into data collection and data management processes.

4) Provide input and guidance into the statistical plan and presentation of statistical findings.

c. Provide data analysis services to primary investigators and other staff members:

1) Conduct statistical analysis with given data sets.

2) Systematically re‐code and clarify data sets to capture the clinical intent of the data.

3) Utilize appropriate statistical software for data analysis.

4) Interpret statistical findings with investigators.

d. Provide training to faculty, residents, students, and other staff members on appropriate research design, data analysis and data presentation:

1) Identify training needs and opportunities for DGMC staff members.

2) Develop and present courses on topics such as the principles of research design, statistical and measurement methods, and other related issues.

3) Present findings either locally or nationally as the opportunity or need arises.

4) Provide administrative support for the management of clinical research operations as necessary:

i. Maintain electronic and paper files of research protocols in accordance with regulatory requirements.

ii. Maintain a status directory of research projects and provide appropriate follow‐up.

iii. Coordinate administrative tasks (scheduling, room reservations, etc.) to support research educational programs.

iv. Review Operating Instructions and Compliance Guidance.

4. Bioinformatics Scientist (1 FTE)

Specific tasks include:

a. The Bioinformatics Scientist will provide statistical services and support compatible with the Clinical Investigations Facility 60th MDG operating capacity and equipment. Will also train staff in principles of research design and bioinformatics tools and use for practical skills for GHSE. This Bioinformatics Scientist will also review professional publications and presentations, providing feedback and editing.

b. The Bioinformatics Scientist shall provide expert guidance to primary investigators on appropriate experimental design:

1) Consult with primary investigators to refine research design and analytic plan.

2) Review proposed research protocols to ensure adequate sample size and statistical analysis.

3) Provide input and guidance into data collection and data management processes.

4) Provide input and guidance into the statistical plan and presentation of statistical findings.

c. Provide data analysis services to primary investigators and other staff members:

1) Conduct statistical bioinformatic analysis with given data sets.

2) Systematically re‐code and clarify data sets to capture the clinical intent of the data.

3) Utilize appropriate statistical software for data analysis.

4) Interpret statistical findings with investigators.

d. Provide training to faculty, residents, students, and other staff members on appropriate research design, data analysis and data presentation:

1) Identify training needs and opportunities for DGMC staff members.

2) Develop and present courses on topics such as the principles of research design, statistical and measurement methods, and other related issues.

3) Present findings either locally or nationally as the opportunity or need arises.

e. Provide administrative support for the management of clinical research operations as necessary:

1) Maintain electronic and paper files of research protocols in accordance with regulatory requirements.

2) Maintain a status directory of research projects and provide appropriate follow‐up.

3) Coordinate administrative tasks (scheduling, room reservations, etc.) to support research educational programs.

4) Review Operating Instructions and Compliance Guidance.

5. Senior Program Manager (Air Force/Space Force/NASA) (1 FTE)

Specific tasks include:

a. Assist in providing oversight of all aspects of studies, especially in regards to Space Force and NASA research collaborations.

b. Organize and prioritize all activities associated with conducting collaborative research for Air Force/NASA/Space Force medical science research.

c. Review and understand effects of space on biomedical research and development protocols, ensuring applicable regulations and guidelines are followed.

d. Participate in grant development in biomedical research with Space Force/NASA/Air Force applications.

e. Coordinate with space focused research partners for research sessions and maintain ongoing projects.

f. Assist GHSE with poster and abstract submissions relevant to space focused medical research.

g. Conduct scientific reviews for protocol development for applicable IRB and IACUC protocols.

h. Abstract required research data elements from paper or electronic patient records or other existing documents or files, in accordance with an approved research protocol and enter these data in the spreadsheets, databases, and/or statistics software.

i. Work with the primary investigator and/or statistician to refine and prepare data sets for analysis.

j. Review professional publications and presentations and locally provide direct feedback on needs and assessments.

k. Identify training needs and opportunities for DGMC staff members.

l. Identify delays and other shortcomings in meeting objectives and develop a contingency plan, as required.

m. Maintain a master calendar for the program and serves as point of contact for NASA/Space Force/Air Force research efforts.

n. Coordinate the submission of research protocol amendments, progress reports, and final report to the study sponsor and the IRB.

o. Immediately report any adverse events to the Medical Monitor or Data Safety Monitoring Board, sponsor and the IRB.

p. Obtain and maintain NIH and CITI training in accordance with local IRB policy

6. Program Manager (Human Studies) (1 FTE)

Specific tasks include:

a. Assist in providing oversight of all aspects of all studies.

b. Organize and prioritize all activities associated with conducting phase I, II and III of these studies in a military setting.

c. Review and understand biomedical research protocols, ensuring applicable regulations and guidelines are followed.

d. Enter required data on paper or electronic case report forms (CRFs), audit records for accuracy, resolve discrepancies, and correct as necessary.

e. Develop patient information and informed consent forms and patient recruitment materials.

f. Administer appropriate forms and processes necessary to complete the research protocol.

g. Advertise the study and assist with enrollment of research subjects.

h. Complete the necessary documents for approval, including the informed consent recruitment materials, and data collection forms.

i. Collect, organize and maintain all essential documents required for study regulatory.

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

k. Coordinate subjects study incentive payments.

l. Schedule subjects for research appointments and external lab requirements.

m. Maintain complete and accurate data on enrollees, data, costs and all relevant paperwork.

n. Abstract required research data elements from paper or electronic patient records or other existing documents or files, in accordance with an approved research protocol and enter these data in the spreadsheets, databases, and/or statistics software.

o. Work with the primary investigator and/or statistician to refine and prepare data sets for analysis.

p. Coordinate statistical and scientific consultation from CIF staff.

q. Identify delays and other shortcomings in meeting objectives and develop a contingency plan, as required.

r. Maintain a master calendar for the study and serve as point of contact for research subjects.

s. Coordinate the submission of research protocol amendments, progress reports, and final report to the study sponsor and the IRB.

t. Immediately report any adverse events to the Medical Monitor or Data Safety Monitoring Board, sponsor and the IRB.

u. Obtain and maintain NIH and CITI training in accordance with local IRB policy

7. Program Administrator (Animal Studies) (1 FTE)

Specific tasks include:

a. Assist in routing studies for approval and maintains communication with Principal Investigator (PI) about all actions- approval, requested changes, or disapproval.

b. Organize and prioritize all documentation associated with studies in a military setting and for maintenance of AAALAC accreditation.

c. Review and understand biomedical research protocols, ensuring applicable regulations and guidelines are followed, including but not limited to AAALAC and DODI 3216.01.

d. Enter required data on paper or electronic IACUC study records, audit records for accuracy, resolve discrepancies, and correct as necessary.

e. Administer appropriate forms and processes necessary to complete the research protocol approvals, adverse event reports, and other protocol processes.

f. Record and/or take notes of all IACUC meetings and complete meeting minutes.

g. Collect, organize and maintain all essential documents required by regulation (USDA, AAALAC, applicable oversight office).

h. Work with the attending veterinarian and/or IACUC Chair to finalize all reports, minutes, and other IACUC documents.

i. Coordinate statistical and scientific consultation from CIF staff and/or external reviewer(s), as appropriate.

j. Identify delays and other shortcomings in meeting objectives and develop a contingency plan, as required.

k. Coordinate the submission, routing and approval of research protocol amendments, progress reports, and final report to the study sponsor and filing in IACUC files.

l. Obtain and maintain NIH, DOD and AALAS or other training in accordance with local IACUC policy

m. Create a list of any materials that need to be ordered, serviced, or replaced and coordinate with the CIF staff/PI to order, service, and replace the needed supplies/equipment.

n. Ensure all personnel involved in the study are added to the protocol and their training is up to date.

o. Catalog samples obtained from each study to ensure they are appropriately identified and their storage location is recorded.

p. Work with IACUC members, Principle Investigators and other persons needed for meetings to develop a schedule for experiments and IACUC meetings and inspections.

q. Facilitate teleconference/web access for IACUC meetings

r. Work with the PI to establish goals, and schedules and coordinates laboratory administration, including purchasing and maintenance of laboratory equipment and supplies. Ensures that all activities are in compliance with organization goals and applicable regulations. Employees have impact on budgeting, controlling costs, planning, scheduling, and procedural change.

B. PERSONNEL QUALIFICATIONS

1. Clinical Research Nurse

a. Education

· BSN (RN) from accredited Nursing Program

· MS/MA preferred

· Certification in Research Nursing recommended, but not required for hire

b. Experience

· RN preferred 5 years of experience in clinical, translational, and military research

c. Knowledge

· Understanding of all aspects of biomedical research protocols, ensuring applicable regulations, and guidelines.

· Understanding of IRB, and/or IACUC (Institutional Animal Care and Use Committee) research protocols and process

2. Chief, Research Oversight, and Compliance

a. Education

· MA/MS (or JD)

· PhD preferred

b. Experience

· Preferred 8-10+ years of experience with IRBs, human protection, and animal welfare programs

· Experience advising, drafting, and coordinating collaborative agreements (CRADAs), invention disclosures, and patents

· Experience as communications advisor on collaborative research development projects

· Strong background in IRB procedures and human subject policies

c. Knowledge

· Extensive understanding of human subject research regulations and federal guidance documents is critical.

· Excellent intrapersonal/communication skills

3. Biostatistician

a. Education

· MA/MS

· PhD preferred

b. Experience

· Preferred 6+ years’ experience in experimental design and statistical support to physicians and nurses performing biomedical research

· Experience in Biomedical Science/Statistics

c. Knowledge

· Demonstrative understanding of biostatistical knowledge and clinical research designs is imperative to provide appropriate guidance for planning, designing, and performing clinical research studies, to train staff in principles of research design and statistical interpretation, and to review professional publications and presentations.

4. Bioinformatics Scientist

a. Education

· BA/BS Computer Science

· Masters or PhD preferred in Bioinformatics, Computer Science, Biomedical Engineering, Computational Biology or related discipline

b. Experience

· Computer Science/Data Management/Data analysis

· Biological and medical experimental techniques, as well as scientific publication and research protocol development.

c. Knowledge

· Demonstrative understanding of bioinformatics knowledge, awareness of publicly available data sets and use, and clinical research designs is imperative to provide appropriate guidance for planning, designing, and performing clinical research studies.

· Strong knowledge of database language(s) SQL, analytical scripting languages (R, Python, Matlab), data management tools, and experience with data processing, statistical analysis, and data visualization

· Data management, curation, aggregation, or analysis of biomedical research or large clinical data sets

5. Senior Program Manager (Air Force/Space Force/NASA)

a. Education

· BS/MS

· Ph.D. preferred

b. Experience

· Ph.D. Astrophysics/Astronomy/Space Sciences; at least 10+ years of experience preferred

· Program Management experience in the area of Space Medicine/Research or related discipline

c. Knowledge

· Ability to organize and prioritize all activities associated with conducting collaborative research for Air Force/NASA/Space Force medical science research

· Extensive knowledge of the challenges of humans in Space/Austere environments

6. Program Manager (Human Studies)

a. Education

· BS/BA/MS in Biomedical Science or related field

· MBA/Ph.D. preferred in Biomedical Science

b. Experience

· Preferred 8+ years’ experience in program and project management

· Conducts biomedical, translational, clinical, and military research; Manages human research projects; Assists GME activities

c. Knowledge

· Ideal to have good project management skills/knowledge and will collaborate with different PIs and residents and manage the human research portfolio as assigned.

7. Program Administrator (Animal Studies)

a. Education

· MA/MS

· PhD preferred

b. Experience

· Program Administrator preferred 8+ years’ experience supporting primarily animal research.

· Ideal to have a background in providing oversight for all types of research related studies/protocols

· Experience conducting trauma research, translational in-vitro models, animal surgical procedures, biochemistry and cell/molecular biology, translational and military research; Manages animal research projects

· Experience in documentation associated with studies in a military setting and for maintenance of Association for Assessment and Accreditation Laboratory Animal Care (AAALAC) accreditation and other required certifications.

c. Knowledge

· Ideal to have exemplary knowledge of protocols, protocol development, and research process.

· This individual will have good project management skills and will understand the process attending veterinarian/Institutional Animal Care and Use Committee (IACUC)Chair, and different PIs.