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CRA Manager - Diagnostics (Science & Biotech)
Durham, NC 27703
Recruited by: Lori Steiner | Principal and Owner | NeedLS See all my Jobs

  • Hiring Company: NeedLS
  • Industry: Science & Biotech
  • Compensation: to be determined
  • Expires: Aug 30, 2020
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Job Description

oversee the progress of clinical monitoring by managing and conducting site evaluation, initiation, and interim close out visits to sites.

Ensure data quality and compliance with protocol, SOPs, and regulations at assigned study sites.
Monitor patient recruitment timelines at sites and report this information to assigned line manager.
Assist with the arranging of study start-up meetings if necessary.
Understand the device, protocol, and therapeutic area in sufficient detail to be able to advise and discuss with the study site personnel.
Conduct site selection activities including site selection visits if necessary.
Provide assistance with regulatory submissions.
Perform site initiation visits, interim monitoring visits, and close-out visits as necessary.
Write and review case report forms if necessary.
Responsible for checking supplies and site compliance with protocol and all current and relevant regulations.
Responsible for conducting source data verification, ensuring all serious adverse events (SAEs) have been reported appropriately, and providing written follow-up requests to the site in order to correct any issues identified at the monitoring visit.
Write and submit site visit reports per specified timelines and guidelines.
Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
Assist the study management in identifying and generating changes in scope.
Serve as mentor for CRAs and those new to the company and/or study.
May conduct field evaluation visits and field training of CRAs.
Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.
Review and approve CRA travel expenses and timesheets.
Perform other duties as requested.
Bachelor's Degree required, preferably in a scientific related field.
Must have at least 5 years' experience as a field monitor CRA.
Experience monitoring IVD studies required.
Must have the ability to train, mentor, and co-monitor with other CRAs.
Must be able to oversee the coordination and resourcing of CRAs to clinical studies.
Prior CRO experience preferred.
Prior project team leadership.
Must have full home office capabilities.
Must have excellent presentation, interpersonal, and oral and written communication skills.
Must have the ability to be flexible and change priorities quickly.
Must be able to strictly follow ICH/GCP guidelines, SOPs, and meet all deadlines.
Must be able to travel up to 75% (1 site visit per week).