Clinical Trials Specialist II

Updated: January 15, 2020
Job ID: 213766
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Clinical Trials Specialist II (CTS II) responsibilities in the Clinical Operations Office (COO) include clinical research/trial protocol development/implementation and management of U.S. Military HIV Research Program (MHRP) clinical research being conducted within the US 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 and team, study sponsor, and/or collaborative institution(s). CTS II will coordinate and participate in 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), 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, assemble a protocol team and facilitate protocol team communication throughout study duration. In addition to protocol development, the CTS II 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 above mentioned regulations. Performs other duties as assigned.

Responsibilities:

  1. 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 Sponsors, and/or collaborative institutions.
  2. Develop final protocols and informed consent forms (ICFs) that meet all regulatory requirements set forth by the DoD, FDA, IRBs/ECs and RAs/HAs located at respective participating sites.
  3. Develop other protocol-related documents including briefing slides, manual of operations, study-specific standard operating procedures, among others.
  4. Manage version control of protocol and supporting documents throughout protocol submission and approval processes, as permitted by Sponsor.
  5. Manage above development of documents through an iterative process that requires regular communications with site teams in the US and at international sites, protocol teams, Sponsors, and collaborators. 
  6. 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).
  7. Submit packets to Walter Reed Army Institute of Research (WRAIR) IRB and US Medical Research and Materiel Command, Office of Research Protection’s Human Research Protection Office (MRMC ORP/HRPO) and manage all submission related responses through approval, study start, and subsequent protocol lifecycle actions.
  8. Liaise with other MHRP 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.
  9. Plan, develop training materials, and oversee site activation procedures to include protocol training of site personnel 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.
  10. After study approval and initiation, management of all subsequent protocol lifecycle actions (amendments, continuing reviews, safety reporting, deviation reporting, etc.) until study closure.
  11. Communications with NIH/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 MRMC ORP/HRPO during all protocol life cycle actions.
  12. Follow up and track in-country submissions, to ensure regulatory compliance, and forward relevant documents to Sponsor, WRAIR and/or HRPO.
  13. Coordinate and lead medically-focused protocol safety review meetings with study Sponsors and international site staff.
  14. Maintenance of up-to-date information in real-time of study progress in the main protocol database.
  15. Compile and provide various program level reports and updates on status and progress of various protocols and projects in portfolio.
  16. Be primary POC 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.
  17. Contribute to general clinical site operations support as needed, including providing support when developing new and inexperienced sites to conduct clinical research.
  18. Compile and generate necessary information needed for funding applications (e.g., work closely with the chair and investigators to complete and submit the application).
  19. Electronic file maintenance of all study documents and maintenance of version control of protocol documents. This includes Investigator CVs and required training records.
  20. Development and review of COO Standard Operating Procedures, policies, guidance documents, tools and templates.
  21. Plan, coordinate and document various required meetings and conference calls to include protocol-specific, site, and other regulatory and clinical operations related meetings/calls.
  22. 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: Bachelors Degree

Minimum Experience: 2 to 4 years of Clinical Research Experience

Physical Capabilities:  Long periods of standing and sitting

Work Environment: Office environment. May be required to travel to international sites 10-15% of time.

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

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