Human Research Protection Regulatory Manager - TBI
The Human Protections Regulatory Manager is responsible for the direction, operation, and management of the Regulatory Affairs and Research Compliance program. S/he will ensure compliance of research programs with applicable sponsor, local, state and federal regulations for human subject research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA).
- Under government guidance, the contractor is responsible for the operation and management of the Regulatory Affairs and Research Compliance program.
- Ensures compliance of research programs with applicable sponsor, local, state and federal regulations for human subject research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA).
- Assists in the development and updating of the DVBIC regulatory compliance policies, standard operating procedures, requirements and related matters.
- Establishes training programs in human subject protection and HIPAA compliance.
- Conducts research compliance monitoring.
- Obtains Scientific review of proposals and protocols.
- Facilitate information flow and acts as liaison between agencies such as USUHS, Federal and Contractor Principal Investigators and research staff, administrative staff, Institutional Review Boards (IRBs), Institutional Animal Care and Use Committees (IACUCs) Institutional Bio-safety Committees (IBCs), research administration offices, Food and Drug Administration (FDA), Office of Human ResearchProtections (OHRP).
- May conduct site monitoring visits to ensure compliance with regulations and human subjects protection.
Minimum Education/Training Requirements:
- Master's Degree required.
- Must have Human Subjects training completed. Training in human subjects' research protection, animal use, bioethics, and HIPAA required.
- Certified as a Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA).
Minimum Experience: 5 years related experience in clinical program management and 10 years' experience in clinical research and/or regulatory affairs arena required. Prior experience within the DoD/VA systems of care
Knowledge, Skills and Abilities: Excellent communication skills, basic clinical acumen, organizational skills and proficiency in research conduct are required. Knowledge of standard qualitative and quantitative data collection
techniques. Ability to follow detailed instructions; work in a team; writing and analytical skills required. Familiarity with social science research methodology is required. S/he must adhere to legal, professional and ethical
codes with respect to confidentiality and privacy.
May encounter patients who are confused, agitated, or abusive.
Supervisory Responsibilities/Controls: May supervise their assistant.
Work Environment: Office and clinical environment. Must be available to travel locally, regionally and nationally.
The contractor will normally work up to 40 hours a week, 0800 to 1630, Monday through Friday (hours may vary).
Must be able to carry light items - up to 25 lbs.
Must be a U.S. citizen.
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.