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Clinical Trials Specialist II

The Henry M. Jackson Foundation


Location:
Bethesda, Maryland
Date:
11/14/2017
2017-11-142017-12-14
Job Type:
Employee
Categories:
  • Clinical Operations
The Henry M. Jackson Foundation
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  • Research Salary

Job Details

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, schedule and monitor study timelines during protocol development and review process in coordination with the protocol chair and team, study sponsor, and/or collaborative institution(s). CTS II will coordinate all aspects of protocol and related documents development including but not limited to: development of a final protocol and submission documents that meet all regulatory requirements set forth by the US Department of Defense (DoD), Institutional Review Boards/Ethics Committees (IRBs/ECs) and Regulatory/Health agencies (RA/HA) located at respective 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 sites to conduct training of site personnel on study, review and approval of site readiness, and develop protocol tools as necessary to assist participating sites in the conduct of clinical studies. 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, IRBs/ECs and RAs/HAs located at respective participating sites.
  3. Develop all other protocol-related documents including briefing slides, manual of operations, study-specific standard operating procedures, among others.
  4. 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. 
  5. 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 and study start.
  6. Plan and oversee site activation procedures to include protocol training of site personnel on protocol specific procedures, conducting mock runs, review and approval of site readiness, and developing protocol tools (including MOPs, SSPs, checklists, clinic flow charts, etc.…) to assist participating sites in the conduct of a clinical trial.  Travel to sites to conduct training, as required.
  7. Manage all subsequent protocol lifecycle actions from development through submission and approval.
  8. Communications with NIH/DAIDS 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.
  9. Follow up and track in-country submissions and forward relevant documents to Sponsor, WRAIR and/or HRPO.
  10. Amendment and CRR management to include development, review and/or submission.
  11. Reportable events and protocol deviation submissions and follow-up.
  12. Maintenance of up-to-date information in real-time of study progress in the main protocol database.
  13. Compile and provide various program level reports and updates on status and progress of various protocols and projects in portfolio.
  14. Be primary POC for protocol-related questions from site implementation teams.
  15. Contribute to clinical site operations support as needed.
  16. Electronic file maintenance of study documents and maintenance of version control of protocol documents.  This includes Investigator CVs and required training records.
  17. Development and review of COO Standard Operating Procedures, policies, guidance documents, tools and templates.
  18. Plan, coordinate and document various required meetings and conference calls to include protocol-specific, site, and other regulatory and clinical operations related meetings/calls.
  19. 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. 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 Director of Human Resources.

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