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Job Runner

 
  • Category: Healthcare
  • Education: Masters Degree
  • Employment Length: fulltime
  • Source: Business
  • Ad #: 11116
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

Clinical Protocol Coordinator – 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 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 and 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 NCCIH 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).
  • Assist with 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 NCCIH staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the NCCIH Intramural Research Program.
  • Prepare draft documents for senior staff review.
  • Attend in-person meeting located at the NIH campus in Bethesda including weekly NINDS CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings as appropriate.
  • 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, NCCIH 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 four (4) years of experience in a clinical research setting.
  • Experience with protocols and clinical trials, such as protocol navigation/clinical research regulatory support or other related field (e.g., quality assurance monitoring or human research subject protection experience).
  • 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

 
Map: Bethesda MD
 
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