Clinical Trials Specialist II or III - Military HIV Research Program
HJF is seeking a Clinical Trials Specialist II or III to support the Clinical Operations Office of the Military HIV Research Program (MHRP) located at the Rockledge office in Bethesda, MD. HJF provides scientific, technical and programmatic support services to MHRP.
Clinical Trials Specialist II or III (CTS II/III) responsibilities in the Clinical Operations Office (COO) include the development, coordination and implementation of clinical research/trial protocols and management of related study activities for the U.S. Military HIV Research Program (MHRP) and the Emerging Infectious Diseases Branch (EIDB) that are being conducted domestically and internationally. The incumbent will prepare protocol development work plans, and schedule and monitor study timelines during the protocol development and review process in coordination with the protocol chair, study team, study sponsor, and/or collaborative institution(s). The CTS will lead and coordinate all aspects of protocol and related document development, from study concept to study closeout, in accordance with all regulatory requirements set forth by the US Department of Defense (DoD), US Food and Drug Administration (FDA), relevant Institutional Review Boards/Ethics Committees (IRBs/ECs) and Regulatory/Health Agencies (RA/HA) located at respective domestic and international participating sites. The incumbent will anticipate, identify and resolve problems that may delay study initiation and progression, work with assembled protocol teams and facilitate protocol team communications for the duration of assigned studies. In addition to protocol development, the CTS will manage site activation procedures to include travel to international sites to conduct training of site study personnel, review and approval of site readiness, develop protocol tools as necessary to assist participating sites in the safe and compliant conduct of clinical studies, and manage all protocol lifecycle actions in accordance with the relevant regulations. The incumbent will also perform other duties as assigned.
- Manage a portfolio of multiple protocols and projects through the development of work plans, study/project timelines and trackers in coordination with protocol teams to include the protocol chairs/PIs, study team, study Sponsors, and/or collaborative institutions.
- Collaborate with investigators and Sponsors to write and develop protocols, site-specific protocol addendums (SSAs) and informed consent forms (ICFs) from concept to approval.
- Create other protocol-related documents including briefing slides, manual of operations, study-specific standard operating procedures, study tools and training materials, among others.
- Manage version control of protocol and supporting documents throughout protocol development, submission and approval processes, as permitted by Sponsor.
- Communicate with site teams, protocol teams, Sponsors, and collaborators in the US and at international sites in order to effectively manage the development of aforementioned protocol and study-related documents.
- Collaborate with investigators and/or clinical trial sponsors to develop scientific and regulatory documents for submission to the FDA (Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and Investigator’s Brochures).
- Submit packets to Walter Reed Army Institute of Research (WRAIR) IRB, US Medical Research and Development Command, Office of Research Protection’s Human Research Protection Office (MRDC ORP/HRPO), and other entities as required; manage all submission related responses through approval, study start, and subsequent protocol lifecycle actions.
- Liaise with other technical and administration leads (lab, data, project management, finance, etc.) when developing protocol documents, project timelines and study trackers to ensure protocol activation requirements are in place.
- Oversee and implement site activation procedures to include planning the agenda, developing training materials, and training of site personnel (to include training on protocol-specific procedures, conducting mock runs, review of site capability and capacity, approval of site readiness, and development of protocol tools—including MOPs, SSPs, checklists, clinic flow charts, etc.) to assist participating sites in the safe and compliant conduct of a clinical trial. Travel to sites to conduct training and site review, as required.
- After study approval and initiation, management of all subsequent protocol lifecycle actions (amendments, continuing reviews, safety reporting, deviation reporting, etc.) until study closure.
- Work with sites and contribute to root cause analyses when deviations and unanticipated events occur in order to ensure proper reporting to IRBs and the development of corrective and prevention action plans (CAPA plans) and any associated tools for quality implementation of study.
- Communications with NIAID/DAIDS, industry and other study Sponsors as well as sites (including but not limited to regulatory contact, pharmacist, CRC, AI and/or PI), WRAIR HSPB and MRDC ORP/HRPO during all protocol life cycle actions.
- Follow up and track in-country submissions to ensure regulatory compliance, and forward relevant documents to Sponsor, FDA, WRAIR and/or HRPO.
- Be primary POC within the programs for protocol-related questions from site teams throughout the life of the protocol. Provide specific clinical operations technical assistance to international and US sites implementing protocols.
- Coordinate and lead, as necessary, protocol safety review meetings with study Sponsors and international site staff.
- Maintenance of up-to-date information, in real-time, of study progress in the main protocol database and other study trackers and reports.
- Compile and/or contribute to various program level reports and updates on status and progress of various protocols/studies and projects in portfolio.
- Contribute to general clinical site operations support as needed, including providing support when developing new and inexperienced sites to conduct clinical research.
OTHER JOB DUTIES: (15%)
- Compile and generate necessary information needed for proposal/grant applications (e.g., work closely with the chair and investigators to complete and submit the application).
- Electronic file maintenance of all study and submission documents and maintenance of version control of documents.
- Development and review of COO Standard Operating Procedures, policies, guidance documents, tools and templates.
- Plan, coordinate and document various required meetings and conference calls to include protocol-specific, site, and other regulatory and clinical operations related meetings/calls.
- Other duties as assigned.
Required Knowledge, Skills, and Abilities: Ability to compile, edit and write protocol documents and progress reports in a clear and concise manner utilizing scientific, medical, and technical writing skills. Ability to work in a fast-paced research environment, and to plan and manage multiple priorities on different timelines. High level of initiative and ability to work with minimum supervision. Ability to quickly and effectively resolve complex issues. Flexibility to handle a variety of tasks and shift priorities as necessary. Excellent organization, time and project management skills with strong communication and interpersonal skills. Ability to effectively interact with local and international external collaborators in a culturally sensitive manner. Ability to work as an effective team member in a virtual environment.
Knowledge of PCs and Macs. Basic knowledge of human anatomy, physiology, infectious diseases and immunology highly desirable.
Minimum Education/Training Requirements:
Clinical Trials Specialist II: Bachelor's Degree required
Clinical Trials Specialist III: Master's Degree required
Clinical Trials Specialist III: Minimum 6-8 years of experience required.
Clinical Trials Specialist II: Minimum 3-5 years of experience required.
Physical Capabilities: Long periods of standing and sitting
Office environment. May be required to travel to international sites 10-15% of time.