Regulatory Affairs Specialist - Murtha Cancer Center Research Program Henry M. Jackson F

Position: Regulatory Affairs Specialist - Murtha Cancer Center Research Program at The Henry M. Jackson F[...]

Regulatory Affairs Specialist - Murtha Cancer Center Research Program job at The Henry M. Jackson Foundation for the Advancement of Milit.... Rockville, MD.
Job Description

Join the HJF Team! HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of MCCRP research protocols with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). This position will be in support of the John P. Murtha Cancer Center Research Program (MCCRP) of the Uniformed Services University of the Health Sciences (USUHS).

The John P. Murtha Cancer Center Research Program at Walter Reed Bethesda is a modern, patient-centric, tri-service military healthcare facility. Its comprehensive core of military and civilian oncologists and other cancer- trained clinicians and researchers provide multidisciplinary cancer-care delivery and patient-family support services. Our Cancer Center, the only DoD Cancer Center of Excellence within the Military Health System, offers its patients access to cutting-edge cancer diagnostic and treatment technologies.

The incumbent will work as a Research Nurse for MCCRP cancer patients in the following areas:
Surgical Oncology, Pulmonary Oncology, and Urologic Oncology. The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners.

HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
Responsibilities

• Assists with the development and Institutional Review Board (IRB) submission of research protocol applications and consent forms on behalf of the study Principal Assists in protocol writing, obtaining the required institutional approvals, and all phases of the protocol lifecycle to ensure that protocol amendments, continuing reviews and adverse events are submitted to the IRB in a timely manner.
• Ensures that protocol and regulatory documents are maintained and are kept up to Maintains study compliance with established local, state, federal, and DoD regulations for human subjects’ research with institutional regulatory direction from USUHS, WRNMMC and HJF. Maintains complete and accurate regulatory-compliant program/study binders.
• Assists with initiation, tracking, management, and close-out of research Completes monitoring reports and follow-up letters, providing summaries of the significant findings, deviations, deficiencies, and suggesting actions to obtain compliance.
• Assists with collecting and monitoring required research training certifications and other study personnel documents for MCCRP investigators and study team
• Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) are adhered to and communicating protocol deviations appropriately per Standard Operating Procedures (SOP), GCP and applicable regulatory
• Performs tasks associated with the institutional publication clearance process for MCCRP manuscripts, posters, and conference presentations; tracks MCCRP scientific publications and provides regular reports to institutional
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Qualifications
Education and Experience

• Bachelor’s Degree is required.
• Minimum of 3-5 years of experience required.

Required Knowledge,

Skills And Abilities

• Basic knowledge of human subjects’ research regulations.
• Must have experience working on regulatory items for research protocols.
• Excellent writing skills (able…