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 an experienced individual to work as a SeniorClinical Protocol Coordinator at the National Institutes of Health 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 10 paid federal holidays and 401K plan.
Access to NIH’s unparalleled resources and niche scientific initiatives
TASKS/SERVICES. The contractor shall:
Provide Clinical Research Support by working closely with the Clinical Director (CD), Clinical Deputy Director (CDD) and Clinical Operations Manager (COM) of the NIDCR (National Institute of Dental and Craniofacial Research) 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
Work directly with the Clinical Operations Manager, Division of Intramural Research (DIR), Office of the Clinical Director (OCD) for work allocation and assignment focused on providing direct protocol management and implementation support to the clinical research program
Attend and participates weekly in the NIDCR OCD and Office of Clinical Trials Over-sight and Management (OCTOM) meetings to help plan and manage DIR clinical re-search; works closely with OCTOM and NIDCR Clinical Research Organization (CRO) contractors in the oversight and management of individual NIDCR clinical trials.
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
Attend NIDCR clinical research study team weekly/bi-weekly QA/QI meetings to pro-vide project management as well direct study support
Identify NIDCR study team resource and management support needs (for individual teams); communicates support needs to the COM for determination of appropriate action plans
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; works 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
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 re-search and regulatory compliance
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.
Maintain ongoing, proactive communication with key NIDCR personnel; gather, pro-vide, and exchange information with investigators, their staff, and other relevant individuals on behalf of NIDCR
Prepare summaries of information for review by NIH staff responsible for managing and overseeing clinical research program(s)
Update and maintain electronic and paper files; copy and distribute materials
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.
Attend and participates in NIDCR monthly meetings to include IWG, Research Nurse/Research Support Staff meetings, OP1 Staff meetings and any other Institute meeting pertinent to work assignment
Attend NIH -wide forums pertinent to work assignment, including monthly Protocol Navigator meetings, OHSRP educational offerings and IRB forums.
REQUIREMENTS. The contractor must have:
Master’s degree in a science or health-related discipline. Three (3) years of specialized experience plus a Bachelors degree is equivalent to a Master’s degree.
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.
Knowledge of the roles, responsibilities, policies, and regulations related to regulatory bodies (i.e. FDA, IRB) with governance over clinical research
Excellent, proactive project management and problem solving skills
Expertise in effective/efficient meeting management
PLEASE APPLY ONLINE
When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
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