ATTACHMENT_5_-_LABOR_CATEGORIES.pdf

ATTACHMENT 5 – LABOR CATEGORIES

Note: The number of FTEs shown below are only estimates based on historical information

* reflects “Key Personnel”

FTEs Labor Category Functional

Area Task Description Key Personnel

1 Administrative Coordinator

Administrative Services

Performs a variety of administrative functions. Schedules appointments, gives information to callers, and takes dictation. Composes memos, transcribes notes, and researches and creates presentations. Generates reports, handles multiple projects, and prepares and monitors invoices and expense reports.

May assist with compiling and developing the annual budget. Relies on experience and judgment to plan and accomplish goals. Performs a variety of complicated tasks. May direct and lead the work of others. A wide degree of creativity and latitude is expected.

1* Biostatistician

Life, Physical, and Social Science Occupations

Provide solution to the clients with question in statistical methodology, statistical analysis, and statistical computing. Ensure the study design, data collection, and statistical analysis is appropriate to meet study objectives.

Provide all documentations including study protocol, statistical analysis plan, statistical analysis system (SAS) programs, SAS programs specification, table, listing, figure for final study report to meet WRAIR and Food and Drug Administration (FDA) guidelines, to include clinical data interchange standards consortium (CDISC) formatting compliance. Ensure that a clinical protocol is both scientifically feasible and has scientific merit. Ensure that the number of animals used is appropriate to obtain sufficient data and/or is not excessive, and the statistical design is appropriate for the intent of the study.

Key Personnel

1* Staff Supervisor Administrative Services

Supervise and provide guidance and direction the laboratory, front desk, and recruitment staff in the Clinical Trials Center (CTC). Provide mentoring, counseling, developing, implementing, and monitoring corrective action plans when appropriate, and assess performance on an annual basis. Facilitate onboarding of new personnel. Act as a liaison between the Senior Clinical Research Coordinator (CRC) and support staff. Coordinate communication between all staff. Ensure the staff adheres to Good Clinical Practice (GCP) guidelines as well as FDA and military regulations. Become familiar with and utilize all pertinent CTC standard operating procedures (SOPs) and study specific procedures (SSPs). Assist in long-range planning and logistics for

* reflects “Key Personnel” special projects. Assist in clinic organization, procurement, and return of clinic equipment, inventory, and purchasing system. Ad hoc duties (when required) in the areas of recruitment, phlebotomy, lab processing, and front desk duties.

Assist in the planning and coordination of volunteer recruitment with the senior recruiter, Clinical Trials Chief, WRAIR’s Public Affairs Office (PAO), and other CTC staff to include: production of recruitment materials, budgeting, and resource allocation. Review and understand all protocol inclusion and exclusion criteria, informed consent forms and processes, and study schedules.

Perform phlebotomy and specimen collections using standard techniques and universal precautions for approved research protocols.

4 Clinical Research Coordinator I

Medical Services

Organize and prioritize all activities associated with conducting phase 1, 2 and 3 studies within a military setting. Review and understand protocol, ensuring applicable regulations and guidelines are followed. Coordinate space and supplies with appropriate personnel. Recruit volunteers for the studies, to include determining volunteer population availability, advertising venues, and discussions with potential volunteers via telephone or e-mail. Volunteer advocate and associated duties. Test article accountability. Documentation, to include gathering, preparing and maintaining appropriate information per applicable FDA regulations and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, source and case report forms, participant rosters, SOPs, etc. Enter required data on case report forms (CRFs) and audit records for accuracy, resolve discrepancies, correct as necessary. Coordinate with external and internal monitors; additionally maintain compliance with specific protocol, SOPs, regulations and guidelines.

3* Clinical Research Coordinator II

Medical Services

Participates in the design, administration and monitoring of clinical trials.

Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives in accordance with FDA regulatory requirements. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Primary job functions do not typically require exercising independent judgment.

* reflects “Key Personnel”

3* Clinical Research Coordinator III (Regulatory)

Medical Services

Organizes research information for clinical projects. Selects and observes subjects and assists with data analysis and reporting. Oversees experiment scheduling and collection of data. Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks. Works under general supervision. Registered Nurses licensed to practice in the state of Maryland, who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314

NOTE: Required to be a Registered Nurse licensed to practice in the state of Maryland and Commission for Case Manager Certification (CCNC) certification, who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314.

All qualified personnel shall meet all credentialing requirements in accordance with Clinical Trial Monitoring of FDA Regulated Clinical Trials Policy (Command Policy Memorandum 2011-59), Army Regulation (AR) 40-68, Clinical Quality Management, issued 26 Feb 2004, WRAIR Command Policy Memorandum 2017-45, “Walter Reed Army Institute of Research Quality Policy,” and USAMRMC Command Policy 2010-07, “Licensure, Credentialing and Privileging (LCP)” issued 10 Mar 2015, or revisions thereof.

2* Clinical Study and Volunteer Assistant

Administrative Services

Researches and analyzes basic and complex issues in the field. Makes recommendations for improving processes, efficiency and practices.

Demonstrates expertise in a variety of the field's concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals and tasks. May provide consultation on complex projects and is considered to be the top level contributor/specialist.

* reflects “Key Personnel”

Clinical Data Manager (Regulatory Writer)

Life, Physical, and Social Science Occupations

Develops, implements, administers, and maintains policies and procedures for ensuring the security and integrity of the company database. Implements data models, database designs, data access and table maintenance codes. Resolves database performance and capacity issues, and replication and other distributed data issues. Relies on experience and judgment to plan and accomplish goals and tasks. Performs a variety of complicated tasks. Leads and directs the work of others.

3 Volunteer Recruiter

Administrative Services

Develops, implements, and maintains a flexible and responsive recruitment plan utilizing targeted advertising that can include social media sites, print, radio, and site visits. Return on investment for strategy used is expected to be reviewed and modified to optimize volunteer availability for studies. Ensures all advertising is approved in accordance with WRAIR and DoD policies.

Performs a variety of administrative functions. Schedules appointments, gives information to callers, and takes dictation. Composes memos, transcribes notes, and researches and creates presentations. Generates reports, handles multiple projects, and prepares and monitors invoices and expense reports.

Relies on instructions and pre-established guidelines to perform the functions of the job. Relies on experience and judgment to plan and accomplish goals and task. Performs a variety of complicated tasks. Works under immediate supervision.

1 Senior Volunteer Recruiter

Administrative Services

Schedule appointments of prospective research subjects for briefings and screenings. Responsible for maintaining the volunteer database: recruitment efforts, appointments, closing volunteers who are no longer available/no contact, etc. Prepare / assist with summarizing data as required for reports.

Organize and prioritize activities associated with conducting non-interventional studies. Review and understand protocol, ensuring applicable regulations and guidelines are followed. Maintain compliance with specific protocol, SOPs, regulations and guidelines. Coordinate space and supplies with appropriate personnel.

2 Phlebotomist Medical Services

Responsible for the collection and handling of blood specimens and related assessment of volunteer safety used in diagnosing and tracking illnesses, drug testing, clinical trials, or other health-related areas requiring a blood sample.

* reflects “Key Personnel”

Relies on experience and judgment to plan and accomplish goals and tasks.

Performs a variety of tasks.

NOTE: Requires completion of an accredited Phlebotomy Technician (PBT) program and passing a national PBT certification exam.

2* Medical Officer Medical

Ensures proper disease diagnosis and qualification for study inclusion, assessment and monitoring. Consults with patients as needed. Recommends and orders tests to determine extent of illness or help diagnose condition.

Relies on experience and judgment to plan and accomplish goals and tasks.

Performs a variety of additional tasks to include protocol review, development, and staff education.

NOTE: Requires a degree in medicine from an accredited school and current license/credentials to practice medicine. Medical Officer shall have a unrestricted license to practice in the state of Maryland in support of all clinical trials. All qualified personnel shall meet all credentialing requirements in accordance with Clinical Trial Monitoring of FDA Regulated Clinical Trials Policy (Command Policy Memorandum 2011-59), Army Regulation (AR) 40- 68, Clinical Quality Management, issued 26 Feb 2004, WRAIR Command Policy Memorandum 2017-45, “Walter Reed Army Institute of Research Quality Policy,” and USAMRMC Command Policy 2010-07, “Licensure, Credentialing and Privileging (LCP)” issued 10 Mar 2015, or revisions thereof.

Laboratory & Specimen Processing Manager

Medical Services

Provides support of research protocols, including cGCP and FDA-regulated clinical trials. Records all laboratory procedures and research project data, data analyses and analytical conclusions of analyses.

NOTE: Experience in collection of urine and blood samples as well as a completed certification in lab specimen collection.

* reflects “Key Personnel”

1* Program Manager/Clinical Portfolio Manager

Administrative

Manage all clinical trial development initiatives. Serve as the primary point of contact for CTC staff. Prepare and manage budgets for all clinical trials and related projects. Assist with preparing the Knowledge Management Plan (KMP) for the CTC. Work closely with the Contracting Officer’s Representative (COR) to monitor, verify, and reconcile expenditure of budgeted funds supporting all clinical trials and other projects. Work closely with the Business Management Office (BMO) to initiate and track assistance agreements for the CTC (e.g., Cooperative Research and Development Agreements (CRADAs), Material Transfer Agreements (MTAs), Institutional Biosafety Committees (IBCs), applications, and Clinical Trial Agreements (CTAs)), ensuring full compliance of contract requirements, schedules, and provisions. Develop and/or provide support for Project Plans, including but not limited to plans for space, supplies and budget management for the execution of protocols. Review and monitor project scope, timelines and deliverables from project initiation to close out. Schedule monthly project team meetings.

Compose submission memos and work with Principal Investigators (PIs) and CRCs to compile documents for protocol submission to the Institutional Review Board (IRB) and other review boards.

Key Personnel

3 Registered Nurse Medical Services

Utilize appropriate CTC standard operating procedures (SOPs), study-specific procedures (SSPs), ICH and GCP guidelines as well as FDA and military regulations. Take vital signs, perform electrocardiograms (EKGs), administer medications and perform phlebotomy when ordered and as required.

Document all subject interactions and data, ensuring completeness and accuracy of entries into the source document. Prepare charts for next day visits, ensuring all required documents are present and the correct version. Call volunteers to follow up on test results and elicit wellbeing, and the presence of any malaria symptoms per protocol. Monitor and help record treatment medications for volunteers who are treated per protocol as directed by study Investigator. Organize and stock assessment rooms throughout the day and in preparation for the next day

NOTE: Required to be a Registered Nurse licensed to practice in the state of Maryland and Commission for Case Manager Certification (CCNC)

* reflects “Key Personnel” certification, who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314.

All qualified personnel shall meet all credentialing requirements in accordance with Clinical Trial Monitoring of FDA Regulated Clinical Trials Policy (Command Policy Memorandum 2011-59), Army Regulation (AR) 40-68, Clinical Quality Management, issued 26 Feb 2004, WRAIR Command Policy Memorandum 2017-45, “Walter Reed Army Institute of Research Quality Policy,” and USAMRMC Command Policy 2010-07, “Licensure, Credentialing and Privileging (LCP)” issued 10 Mar 2015, or revisions thereof.

2* Quality Assurance Officer

Life, Physical, and Social Science Occupations

Responsible for all onsite Clinical Trial activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Facilitate quality assurance monitoring by study sponsors. Relies on experience and judgment to plan and accomplish goals and tasks. Performs a variety of tasks. May lead and direct the work of others.

1 Research Records Manager

Administrative Services

Performs archival duties involving reference, arrangement, description, evaluation, and preservation and rehabilitation of records. Work is performed under the general supervision of a supervisor. Work is evaluated for compliance to laws and regulations concerning preservation of applicable regulatory documents, and on the basis of thorough, effective, and timely completion of assignments. Incumbent exercises judgment in applying laws, regulations, and established procedures.

1 Clinical Pharmacologist

Medical Services

Lead protocol development efforts at the CTC for intramural and extramural studies. Contribute expert input into preclinical, clinical, regulatory, and analytical documents (inclusive of pharmacokinetic/pharmacodynamic (PK/PD) modeling reports). Attend meetings with internal and external parties and represent CTC with Sponsor and FDA-related document submissions.

Coordinate with appropriate responsible parties and/or prepare summary documentation, to include IRB protocol preparation, regulatory liaison with

* reflects “Key Personnel” investigators, subject matter experts, and other federal entities. Maintain timely communication to and among team members.

3 Regulatory Scientist

Life, Physical, and Social Science Occupations

Provide regulatory support to agency product development teams, filing necessary applications and handling government interactions pertaining to the regulation process for products requiring governmental approval. Assists in developing procedures to ensure regulatory compliance. Relies on experience and judgment to plan and accomplish goals and tasks. Performs a variety of tasks. May lead and direct the work of others.

1 Technical Writer and Social Science Occupations

Prepare complex, multi-volume documents requiring advanced word processing and formatting, indexing, generation of table of contents, and manual pagination according to FDA regulations. Ensure accuracy, completeness, and compliance of regulatory documents before submission to the FDA. Develop and maintain trial master files for accountability of documentation and data required for regulatory submissions. Ensure adherence to the American Medical Association (AMA) manual of style and/or style guide provided by sponsor.

1 Program Manager and Social Science Occupations

Assist in defining and developing clinical research strategy and study protocols. Manage external clinical research organization (CRO) and clinical study site relationships. Audit operations to ensure compliance with protocol and applicable regulations. Assist with creating and managing internal and external budgets for research protocols. Provide assistance in creating and documenting policies and Standard Operating Procedures (SOPs) for clinical operations. Lead the troubleshooting process to reach resolutions for any issues that arise during the course of a study.

1 Biomedical Science Writer

Life, Physical, and Social Science Occupations

Conduct research and write content about a wide range of biomedical research and public health topics. Write and edit feature articles, news releases, fact sheets, infographic content, and other print and digital products. Interview scientists and thought leaders at major U.S. research institutions (Government and non-government organizations (NGOs)). Attend scientific conferences and

* reflects “Key Personnel” summarize proceedings on behalf of the government. Contribute to social media and video projects. Work directly with clients and collaborate with other staff members

1 Principal Investigator

Life, Physical, and Social Science Occupations

Provide assistance for vaccine development by the MRMC, WRAIR, and other developers. Provide assistance and expert knowledge for GMP production facilities at WRAIR and elsewhere as benefits WRAIR. Review production and clinical development plans for WRAIR and other institutions. Perform site visits for manufacturing facilities being planned or in operation, as benefits WRAIR processes. Assist in interviews for staffing qualified personnel for vaccine production and testing. Act as a Subject Matter Expert to review proposals for viral vaccine development and/or speaking engagements.