Kelly Services Clinical Protocol Coordinator/Navigator - NIH - Bethesda, MD in Bethesda, Maryland
Clinical Protocol Coordinator/Navigator – NIH – Bethesda, MD
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 Coordinator 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
Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com at http://www.kellygovernmentsolutions.com/
TASKS. The contractor shall:
Protocol navigation and regulatory writing:
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 protocols and informed consents meet regulatory requirements and are written in a compatible format 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.
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 meeting 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.
Attends 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 related scientific discipline; two (2) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.
Minimum of two (2) years of related experience.
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.
PLEASE APPLY ONLINE.
Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.
AboutKelly Services ®
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 .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm