Human Subject Protection Specialist/ Team Lead - Ft Detrick

Ft Detrick, MD
Apr 10, 2017
May 02, 2017
Full Time
    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 HSP regulatory and cadaver use requirements.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 PI following review and approval by the HRPO AA. Provide regulatory-based written initial reviews of protocols using standardized checklists.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.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.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. 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 PHR contractor shall travel to sites, as needed, to support HRPO federal personnel in this task.Engage in email and telephone communication with the Principal Investigator and key study personnel to address questions, concerns, and outstanding issues.Report weekly team productivity to Onsite PM and Senior PMDevelop written orientation plans (using Orientation Schedule template) for new team members and deliver to Onsite PM and Senior PM 2 weeks prior to new start of employee.Verify orientation schedule and enter into Outlook calendarProvide weekly updates to Onsite PM and Senior PM regarding the orientation progress achieved by new employees (3 month orientation goal)Ensure that all new hires complete required HSP training
Education Masters Degree in a scientific discipline.

  • 8-10 years of related experience in scientific research, analysis and/or engineering.
  • Must be a U.S. citizen. / Must be able to obtain a National Security Clearance.
  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 - Minorities/Females/Protected Veterans/Individuals with Disabilities.