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Sr. Clinical Res Monitoring Specialist

  • Location: California
  • Salary: US$60.00 - US$68.00 per hour per hour
  • Job Type:Contract

Posted 29 days ago

Responsibilities include but are not limtied to:

  • Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
  • Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities
  • Act as a mentor to new or junior level employees
  • Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements
  • Contribute to the development of clinical protocols, informed consent forms, case report forms and team projects
  • Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition
  • Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded
  • Edit/amend informed consent documents