Clinical Research Associate, Sponsor Dedicated

Lifelancer
Gloucester, MA
Category Research
Job Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Clinical Research Associate, Sponsor Dedicated, dedicated to site management and monitoring work in the field.

Requirements

  • Perform site monitoring visits in accordance with contracted scope of work and Good Clinical Practice
  • Work with sites to adapt, drive, and track subject recruitment plan
  • Administer protocol and related study training to assigned sites
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans
  • Collaborate and liaise with study team members for project execution support as appropriate

Benefits

  • 401k Matching
  • Health and welfare benefits
  • Bonus and/or other forms of compensation
  • Generous Paid Time Off
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