Senior Clinical Protocol Coordinator Job Bethesda area,Maryland USA,Healthcare

Kelly Government Solutions is seeking an individual to work on-site as a Senior Clinical Protocol Coordinator supporting the National Institute of Dental and Craniofacial Research (NIDCR) at the NIH in Bethesda, MD.

This is a long-term contract position which offers:

Competitive compensation and comprehensive benefit package
Optional health, vision, and dental plans
Vacation leave as well as paid federal holidays and 401K plan.
Access to NIH’s unparalleled resources and niche scientific initiatives

KEY TASKS

(1) Provide clinical research support including direct protocol management and implementation support to the clinical research program within the National Institute of Dental and Craniofacial Research (NIDCR) Office of the Clinical Director (OCD)

(2) Provide oversight and management of the clinical research program supported by the Institute

(3) Work closely with all NIDCR 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

(4) 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

(5) Work closely with Protocol Navigators to ensure IRB submissions are accurate and timely, provide quality reviews of NIDCR clinical research protocols and associated documents

(6) 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).

(7) Educate and provide guidance to clinical research investigators, research nurses/coordinators, patient care coordinators and other research support staff in clinical research and regulatory compliance

(8) Prepare summaries of information for review by NIH staff responsible for managing and overseeing clinical research programs

(9) Update and maintain electronic and paper files; copy and distribute materials as needed

(10) Work with Institute leadership staff and clinical study staff members to coordinate logistics for in-person meetings, monthly teleconferences, or video conferences, prepare meeting materials, such as spreadsheets, letters, rosters, agendas, presentations, and meeting minutes/summaries.

(11) Attend NIH-wide forums pertinent to role including monthly Protocol Navigator meetings, OHSRP educational offerings and IRB forums

KEY REQUIREMENTS

(1) Master’s degree in a science or health-related discipline. Three (3) years of specialized experience plus a bachelors degree is equivalent.

(2) Minimum of five (5) years of work experience in a clinical research environment that includes clinical research coordination, clinical trial program management, and/or clinical trials operational support

(3) Knowledge of the roles, responsibilities, policies, and regulations related to regulatory bodies (i.e. FDA, IRB) with governance over clinical research

(4) Ability to work on-site in the NIH Clinical Center in Bethesda, MD.

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