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Clinical Research Coordinator

Nextaff Raleigh
Durham, NC
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Direct Hire, Clinical Research Coordinator in Durham, NC

Hours: Monday - Friday, 9AM - 5:30PM

Salary: $50k - $60k/annually

*Must share proof of vaccination*

This position will coordinate and assist with the study start-up process at clinical trial sites by serving as the main point of contact for site personnel throughout the start-up process. The position will also assist investigators with IRB submissions and maintain appropriate documentation for study investigators and regulatory approvals. It includes coordinating FDA submissions and maintaining appropriate records in the trial master file. Performing review of essential study documents to ensure that sponsor and investigator obligations are being met and participating in preparation and reconciliation of trial documents related to internal and external audits is also expected.

Additionally, the position will provide general support to the Clinical Research team as needed. This includes assisting with monthly and quarterly department meetings and supporting external meetings. This position will also contribute to the overall department organization and complete administrative tasks as required to ensure efficiency.

Clinical Research Coordinator Primary Responsibilities:

  • Organize and provide submissions packets for site IRBs
  • Assist investigators with initial IRB submissions, modifications, and renewals
  • Using study specific templates, obtain necessary regulatory documents from investigators
  • Provide study binders and test materials to study sites
  • Assist with preparation, organization, and maintenance of FDA submission documents for IDE, compassionate use, and other submission types
  • Hold responsibility for the set-up, maintenance, and close-out of the trial master file
  • Complete administrative tasks such as shipping, procuring supplies, and assisting with meetings to contribute toward overall goals of the team


Clinical Research Coordinator Position Qualifications:

  • High school diploma and related professional experience
  • Knowledge of GCP guidelines
  • Excellent computer skills, including an intermediate knowledge of MS Office
  • Ability to organize and complete tasks in a timely manner
  • Strong written and verbal communication skills
  • Positive attitude, self-motivated and collaborative team spirit a must!


Clinical Research Coordinator Benefit Overview:

  • Medical and Dental
  • HSA Account
  • Life / Short & Long Term Disability
  • FSA Account
  • 401k Fidelity
  • 3 weeks’ vacation per year (prorated upon hire date) + medical/sick days and personal days

Nextaff Raleigh

Address

Durham, NC
USA

Industry

Healthcare