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 one of the most prestigious research organizations in the world. We are currently seeking a Clinical Protocol Navigator with IRB Submission experience to work onsite with the National Institutes of Health in Bethesda, MD.
This is a long-term contract position which offers:
Competitive salary with comprehensive benefit package
Tremendous growth opportunity
Opportunity to work at NIH, the world's foremost medical research center
Provide clinical trials regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned.
Work with Principal Investigators (PIs) on protocol writing and editing (including format and addition of administrative sections); prepare amendments, continuing reviews, problem reports, including all necessary forms.
Work with research staff on the development of clinical research and clinical trial protocols, informed consent documents, and other regulatory or study-related documents.
Review and ensure that protocols and informed consents meet regulatory requirements and are written in a format compatible with the guidelines.
Work with research teams and NINDS Clinical Trials Unit (CTU) staff to prepare submissions to the appropriate regulatory bodies (e.g. Institutional Review Board, Data and Safety Monitoring Entity, Radiation Safety Committee, etc.,)
Protect and ensure the safety of patients on research protocols through reporting of toxicities, trends in protocol results, and other concerns to the PI and Medically Responsible Investigator (if not the PI).
Collaborate with staff on IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
Manage, track and coordinate regulatory activities for all assigned protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closures.
Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports
Work with PI and associated research staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies as needed.
Program support as protocol navigator
Work with the NINDS CTU and NINDS staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program.
Prepare draft documents for senior staff review.
Attend in-person meetings located at the NIH campus in Bethesda including weekly CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.
Initiate and oversee revisions to documents as indicated in corrective and preventive action plans.
Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, CTU-staff, and safety, regulatory, and monitoring entities.
Coordinate with other offices (e.g., Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication) to integrate and ensure consistency of new/revised documents with policies.
Attend training activities to maintain a current clinical trial and Good Clinical Practice (GCP) knowledge base, in order to serve as an expert resource to the client in a regularly changing field.
REQUIREMENTS. The contractor must have:
Master’s degree in a discipline related to biomedical research/clinical trials/health or a related discipline; three (3) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.
Minimum of four (4) years of related experience, with two (2) years of experience working in the field of clinical research.
Experience in a clinical research setting with protocols and clinical trials, such as protocol navigation/clinical research regulatory support or other related field (such as quality assurance monitoring; human research subject protection work).
Strong communications skills, both oral and written.
Excellent analytical, organizational and time management skills.
The ideal candidate would have:
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).
Knowledge of regulatory requirements, FDA regulations (specifically IND regulations), Good Clinical Practices (GCPs), international guidelines, and other guidelines for clinical research, including the requirements of the institutional review board (IRB).
Experience with electronic data-management including proficiency in navigating clinical trials databases as well as other platforms including MS Excel, etc.
Experience interacting with the FDA, IRBs, and other regulatory bodies in order to make all required regulatory submission and address questions/stipulations.
Experience with Contract Research Organizations (CROs) and pharmaceutical companies.
Experience related to clinical trial operations (e.g., development of Case Report Forms [CRFs]/electronic CRFs [eCRFs]), regulatory submission, patient scheduling and communications).
Internal Number: 1563692
About Kelly Government Solutions
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As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
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