Human Subjects Protection/Clinical Trials Manager in Durham at General Dynamics Information Technology

Date Posted: 9/9/2018

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Job Description

General Dynamics Information Technology – Health and Civilian Solutions Division is currently looking for a Human Subjects Program Manager to join our team. The position will support our client at the Office of Research Protection - US Army Medical Research and Material Command (MRMC). This position is based in Ft. Detrick – Frederick, Maryland.

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Human Research Protection Office :

 Job Description

  • Serve as Project Manager and provide on-site supervision of contract personnel assigned to the ORP. Function as a HSPS and manage a small caseload of protocols to ensure he/she remains current on process and can provide appropriate guidance to contract staff.
  • Provide on-site, day-to-day work supervision for the contract personnel employed at the ORP, to include assigning work to HRPO contractor personnel.
  • Maintain a positive work environment to facilitate staff success in their job performance.
  • Ensure that personnel are adequately oriented to their duties and to the standards and expectations of the ORP within the initial 3 months of employment (with accommodation for Common Access Card issuance delay).
  • Provide quality assurance oversight for contractor activities and ensure that deliverables meet all timeliness and quality standards.
  • Coordinate with the HRPO and IRBO senior leadership on matters relating to the contractor’s conduct of all aspects of human subjects protection and cadaver use compliance oversight, to include regulatory reviews, participation in investigators meetings, staff assistance visits, and completion of special projects as requested by the leadership of HRPO and IRBO.
  • oversee all aspects of the contractors’ responsibilities for protocol lifecycle management from initial proposal/protocol review through receipt of the final study report, and shall ensure that protocols, amendments, continuing reviews, reportable study events, and final report actions are comprehensively reviewed for compliance with Federal, DoD, DA, state, host nation, and USAMRMC regulations, policies, and guidelines and human research ethical standards.
  • Coordinate with onsite Team Leads 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.
  • Ensure that accurate regulatory and procedural guidance are provided in a timely and professional manner.
  • Contractor support for the HRPO electronic review transition plan to a new electronic review and archive system.
  • Ensure that all additional contractor duties are performed in a timely and professional manner.
  • Perform supervisory functions for contractor staff and monitor quality of deliverables and workplace performance.
  • Provide expert human subjects protection advice to staff when requested.
  • Assign appropriate HSPS and HSPS Administrative Support contractor personnel to provide support for the Electronic HRPO review transition plan to a new electronic protocol review and archive system.
  • Ensure continued and up-to-date HSPS professional competency through continuing education and participation in other professional activities.
  • Provide a Monthly Progress Report.

Job Requirements

  • 8-10 years of related experience in scientific research, analysis and/or engineering.
  • Must be U.S. citizen and be able to obtain a National Agency Check with Inquiries (NACi) clearance.
  • Prior regulatory experience required.
  • Prior management experience required.
  • CIP certification preferred.
  • PMP certification preferred.
  • Prior experience managing government contracts preferred.

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As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/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 veteran status, or any other protected class.