PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
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.
Specific HIR 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.
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.
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. On an as-needed basis, the Program Manager may task the Team Lead/HIR to complete review actions for protocols in post-approval oversight.
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. 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 Team Lead/HIR 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.
8-10 years of related experience in scientific research, analysis and/or engineering.
U.S. citizen is a contractual requirement with the ability to obtain and maintain a favorable a T1 security investigation. _____________________________________________________________For more than 50 years, General Dynamics Information Technology has served as a trusted provider of information technology, systems engineering, training and professional services to customers across federal, state, and local governments, and in the commercial sector. Over 40,000 GDIT professionals deliver enterprise solutions, manage mission-critical IT programs and provide mission support services worldwide. 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.
Internal Number: 2018-44146
About GDIT- Military Health Solutions
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. Headquartered in Fairfax, Va., with major offices worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services. General Dynamics Information Technology is one of two business units in the General Dynamics Information Systems and Technology business segment.