Clinical Research Coordinator

We are currently searching for a Clinical Research Coordinate to provide support to the National Institutes of Health (NIH). This opportunity is a part-time position with MSC and it is on-site in Rockville, MD.

• Devise working plans and standards of practice for the identification, screening, randomization and enrollment of subjects in IRB approved clinical trial protocols at sponsored international sites in collaboration with local investigators.
• Oversee the implementation all trial related activities according to each individual IRB approved clinical trial protocol, established Standard Operating Procedures (SOPs), sponsor specifications and Good Clinical Practice (GCP).
• Build and maintain excellent communication with Principal Investigators and collaborators at international sites in order to conduct high quality clinical trials.
• Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in a timely fashion.
• Coordinate with international colleagues site initiation activities as well as oversee the set-up and maintenance of studies.
• Create and submit regulatory and associated documents as needed to start new clinical trials.
• Maintain both new and ongoing IRB processes.
• Revise IRB submissions in response to identified problems and resolve issues in a timely manner.
• Review audit findings from the medical monitor and/or internal auditor and discuss with Principal Investigators when needed.
• Prepare reports summarizing clinical and research information obtained for the purpose of communication with the IRB and publication.
• Interface with clinical laboratories, contract laboratories, NIH research laboratory personnel and outside laboratories to ensure correct and timely specimen collection and track results of testing.
• Track and obtain knowledge to observe and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner in collaboration with international colleagues
• Attend all clinical operations meetings and conduct strategic planning as needed.

• RN, PA, NP Degree or equivalent preferred
• 2 years’ experience working as clinical study coordinator required
• Must have experience with the IRB process and clinical trial regulatory submissions
• French language skills desirable but not required.
• Must be able/willing to travel to study sites in Mali (2-3) times per year for approximately (5-7) days per trip
• Must be able to work a part-time schedule (30hrs/week)

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Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

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