Job Vacancy Announcement - Clinical Trials Program Coordinator
Department of Health and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Office of Clinical Research (OCR)
Clinical Trials Operations Branch
The Office of Clinical Research at the National Institute of Mental Health is recruiting for a Clinical Trials Program Coordinator to fill the position of Chief of the Clinical Research Education Support and Training (CREST) Program for the Clinical Trials Operation Branch (CTOB) at its Rockville, MD site. The Branch’s mission is to provide institute-wide coordination, project management and operational oversight to ensure and improve the quality, safety and efficiency of NIMH-funded clinical research.
The CREST Chief will lead NIMH’s Clinical Research Support, Education and Training (CREST) activities and assist in providing operational oversight of NIMH-funded clinical research. Specific responsibilities of the position include strategic guidance and leadership in the development and implementation of the NIMH CREST program which uses a site-monitoring framework to provide hands-on education, support, and training on the conduct of clinical research to ensure the protection of human subjects, data integrity and compliance with federal regulations, as well as institutional and NIMH policies. The CREST Chief is responsible for ensuring the highest level of quality assurance and control for clinical research sponsored by NIMH. The incumbent will also support the development of study monitoring plans and review the risk-based audit/monitoring of clinical research studies, including conducting on-site monitoring activities of clinical research.
The candidate should have specialized knowledge of clinical research site monitoring, mental health clinical research, federal regulations related to research with human subjects, and good clinical practice regulations acquired from extensive experience in the clinical research site monitoring, as well as the conduct, implementation and oversight of single and multi-site clinical trials. The candidate should also have experience in the development and implementation of site monitoring plans, and data and safety reporting procedures. In addition, the candidate should have extensive knowledge of the types of data sources, data flow, and systems interactions necessary for the timely and accurate collection of data to ensure the quality and integrity of the trial. Strong collaborative, organizational, oral, written, and communication skills are required. Seeking expertise in the fundamentals of clinical trials, as well as experience as a senior clinical research site monitor, and familiarity with regulatory requirements and data and safety monitoring.
Ph.D. in related discipline; three (3) years of specialized experience plus a master’s degree is equivalent to a Ph.D.; five (5) years of specialized experience plus a BA/BS degree is equivalent to a Ph.D. Minimum of nine (9) years of experience conducting and monitoring clinical research studies. Senior CRA; CCRA (Certified Clinical Research Associate). Current knowledge of FDA regulations, Good Clinical Practices (GCP), NIH policies, and human subjects regulations. Completion of the Barnett International 30-Hour Clinical Research Auditing Certification Program within 6 months of hire.
The incumbent will be selected at a salary commensurate with their qualifications and experience. In addition, full benefits, including leave, health and life insurance may be provided. This position is remote eligible.
How to Apply
Job Title: Clinical Trials Program Coordinator
Pay Plan/Grade(s)/Series: GS-0601-13; GS-0601-14
601-13 MP https://www.usajobs.gov/job/719706300
601-14 MP https://www.usajobs.gov/job/719711100
Open date: Monday, 04/17/2023
Close date: Friday, 04/21/2023
HHS and NIH are equal opportunity employers
The NIH encourages the application and nomination of qualified women, minorities, and individuals with disabilities. HHS and NIH are Equal Opportunity Employers.