Kelly · 8 hours ago
Senior Clinical Protocol Coordinator
Bethesda, MD
Full-time
Onsite
Senior Level
$130K/yr - $150K/yr
5+ years expKelly Government Solutions is seeking a Senior Clinical Protocol Coordinator to support the National Institute of Dental and Craniofacial Research (NIDCR) at the NIH. The role involves providing clinical research support, managing protocols, ensuring regulatory compliance, and guiding research teams in clinical research documentation and processes.
OutsourcingProfessional Services
Responsibilities
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)
Provide oversight and management of the clinical research program supported by the Institute
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
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
Work closely with Protocol Navigators to ensure IRB submissions are accurate and timely, provide quality reviews of NIDCR clinical research protocols and associated documents
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)
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
Prepare summaries of information for review by NIH staff responsible for managing and overseeing clinical research programs
Update and maintain electronic and paper files; copy and distribute materials as needed
Work with Institute 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
Attend NIH-wide forums pertinent to role including monthly Protocol Navigator meetings, OHSRP educational offerings and IRB forums
Qualification
Required
Master's degree in a science or health-related discipline. Three (3) years of specialized experience plus a bachelors degree is equivalent
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
Knowledge of the roles, responsibilities, policies, and regulations related to regulatory bodies (i.e. FDA, IRB) with governance over clinical research
Ability to work on-site in the NIH Clinical Center in Bethesda, MD
Benefits
Optional health, vision, and dental plans
Vacation leave as well as paid federal holidays
401K plan
Company
Kelly
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H1B Sponsorship
Kelly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (85)
2024 (76)
2023 (59)
2022 (74)
2021 (81)
2020 (65)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Chris Layden
Chief Executive Officer
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Nicholas Zuhlke
Vice President, Controller, and Chief Accounting Officer
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