Clinical Trial Protocol Coordinator - Nih

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking a Clinical Trial Protocol Coordinator at the National Institutes of Health in Bethesda, MD.

This is a contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Vacation leave as well as 10 paid federal holidays and 401K plan.

- Access to NIH’s unparalleled resources and niche scientific initiatives

The contractor shall:

• Attend NIDCR clinical research study team weekly/bi-weekly QA/QI meetings to provide project management as well direct study support
• Work closely with all NIDCR DIR clinical research teams to navigate clinical studies through various phases of the protocol lifecycle while at the same time ensuring regulatory compliance with NIH, local, state, and federal policies/procedures
• Stay abreast of all Human Subject Protections and research-related regulations and policies including but not limited to all NIH, local, state, and federal regulations (i.e. FDA, IRB, ICH).
• Prepare summaries of information for review by NIH staff responsible for managing and overseeing clinical research program(s)
• Work closely with Protocol Navigator(s) to ensure IRB submissions are accurate and timely; to provide quality reviews of NIDCR clinical research protocols and associated documents
• Work with the NIDCR COM to support the planning (agendas) and execution (minutes) of various meetings, including meetings with individual study teams, Investigator Working Group (IWG) meetings and Research Nurse/Support Staff meetings.
• Work with NIDCR leadership staff and clinical study staff members to: Coordinate logistics for in-person meetings, monthly teleconferences, or videoconferences: Prepare meeting materials, such as spreadsheets, letters, rosters, agendas, presentations, and meeting minutes/summaries.
• Maintain ongoing, proactive communication with key NIDCR personnel; gather, provide, and exchange information with investigators, their staff, and other relevant individuals on behalf of NIDCR
• Work directly with the NIDCR study teams: in the development of clinical research documents including research protocols, informed consent documents, case report forms, study team worksheets and other documents; to guide the preparation of regulatory agency reports, including IRB, DSMC, Scientific Review and FDA documents
• Provide Clinical Research Support by working closely with the Clinical Director (CD), Clinical Deputy Director (CDD) and Clinical Operations Manager (COM) of the NIDCR Division of Intramural Research (DIR), Office of the Clinical Director (OCD) to provide oversight and management of the clinical research program supported by the Institute

CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED.

The contractor must have:

• Strong analytical, communications skills, both oral and written
• Three (3) years of specialized experience plus a Bachelors degree is equivalent to a Master’s degree.
• Master’s degree in a science or health-related discipline.
• Excellent, proactive project management and problem solving skills
• Expertise in effective/efficient meeting management
• Knowledge of the roles, responsibilities, policies, and regulations related to regulatory bodies (i.e. FDA, IRB) with governance over clinical research
• Minimum of five (5) years of experience in a clinical research environment; clinical research coordination/management of programs, clinical operations and/or research analyst experience preferred.
• Excellent leadership, analytical, organizational and time management skills

Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.