Job Vacancy Announcement – Clinical Trials Program Coordinator, Office of Clinical Research
Department of Health and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Office of Clinical Research
Clinical Trials Program Coordinator
The Office of Clinical Research at NIMH is recruiting for a Clinical Trials Program Coordinator in 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 Clinical Trials Program Coordinator provides leadership in the planning, management, and operational oversight of NIMH-funded clinical trials. This includes strategic guidance and leadership in the development and dissemination of innovative methodologies to improve the efficiency and impact of clinical research supported by the NIMH. The Clinical Trials Program Coordinator is responsible for ensuring the highest level of quality assurance and control for clinical research sponsored by NIMH. Specific responsibilities of the Clinical Trials Program Coordinator include the development and implementation of guidelines and standards for the conduct of clinical trials in order to ensure data quality and compliance with regulatory requirements for clinical research. The incumbent will also support the development of project management plans, study monitoring plans, and review the risk-based audit/monitoring of clinical research studies, including conducting on-site monitoring of clinical trials coordinating centers and/or clinical sites.
The candidate should have specialized knowledge of clinical trials research (mental health preferred), good clinical practice regulations, project administration, and project management acquired from extensive experience in the conduct, implementation and oversight of single and multi-site clinical trials. The candidate should also have experience in the development and implementation of monitoring and data sharing 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. Also, strong collaborative, organizational, oral, written, and communication skills are required.
A Ph.D. in Life Sciences or other related discipline is preferred. The candidate should have expertise in the fundamentals of clinical trials, as well as experience in clinical data management, and familiarity with regulatory requirements and data and safety monitoring. 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.
How to Apply
Interested candidates should send a letter of interest, including a curriculum vitae to NIMHsearch@mail.nih.gov. Open to status applicants only.
The NIH encourages the application and nomination of qualified women, minorities and individuals with disabilities.
The HHS and NIH are Equal Opportunity Employers.