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Human Subjects Protection Team Lead - Military veterans preferred

2019-04-01
General Dynamics Information Technology (www.gdit.com)
Science/Biotech

/yr

  full-time   employee


Frederick
Maryland
United States

General Dynamics Information Technology � Federal Health Sector is currently looking for an IRB Clinical Research Team Lead to join our team. The position will support of the Office of Research Protections� Human Research Protections Office (HRPO). This position is based in Ft. Detrick � Frederick, Maryland.

In addition to serving as a HRPO Initial Reviewer (HIR), the Team Lead HSPS shall collaborate with the On-Site Program Manager to manage team workload, monitor and report team productivity, serve an immediate expert resource for all team members and as a mentor for new personnel.

Responsibilities include:
Using Government-provided policies, procedures, checklists, and information systems, the Team Lead/HIR shall accelerate an investigator�s pursuit of HRPO approval through timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to the USAMRMC to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRMC human subjects protection regulatory and cadaver use requirements.
The Team Lead/HIR shall provide comprehensive, timely, professional quality and fully documented initial reviews of research supported by the USAMRMC. The purpose of these reviews is to assure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRMC human subjects protection and cadaver use regulatory requirements and to delineate deficiencies and areas of noncompliance. These reviews support recommendations regarding regulatory and ethical issues for submission that are provided to the Principal Investigator following review and approval by the HRPO Approval Authority. The Team Lead/HIR shall provide regulatory-based written initial reviews of protocols using standardized checklists.
The Team Lead/HIR shall formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research and cadaver use. This includes identification and assessment of noncompliance when the research is conducted prior to HRPO approval. On an as-needed basis, the Program Manager may task the Team Lead/HIR to complete review actions for protocols in post-approval oversight.
The Team Lead/HIR shall provide accurate information, assistance and documents to customers and HRPO federal personnel when requested with appropriate professionalism in a timely manner. This requires active management and updating of the protocol files and the information management systems used to track information related to protocol review. This also requires active backup of HSPS working materials to the HRPO�s shared computer drive to facilitate review of future actions by team members.
The Team Lead/HIR shall provide support for staff assistance visits and HRPP assessments designed to monitor compliance with human subjects protection regulations and make recommendations for improvement. This includes assisting with planning, formulation of agenda, and preparation of materials for use during the visit, to include any educational presentations. The employee shall participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants, and conduct detailed policy and regulatory record reviews and assist with preparation of after-action reports. The HIR shall travel to sites, as needed, to support HRPO federal personnel in this task.
The employee shall engage in email and telephone communication with the Principal Investigator and key study personnel to address questions, concerns, and outstanding issues.

Education/Experience:
Master�s Degree in a scientific discipline.
8-10 years of related experience in scientific research, analysis and/or engineering.
Must be U.S. citizen required (needed to obtain NACI clearance as per contract)


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