Senior Clinical Research Associate (cra)

Biovectra

$80,800.00 - $151,500.00pyr; bonus, stock + benefi...
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Study monitoring visits and reports
Gcp, protocol, and regulatory adherence
Site regulatory document collection
** Biovectra is seeking a Senior Clinical Research Associate (CRA) for a fully remote position. The role involves conducting study monitoring visits, ensuring compliance with protocols and regulations, and supporting various clinical research activities. **

Job Summary

  • Performs all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits.
  • Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits.
  • The Senior CRA will also be expected to take on responsibilities such as assisting in developing study-related plans and documents and assisting in training new CRA staff.

Matching Summary

Match Score: 75

** Biovectra is seeking a Senior Clinical Research Associate (CRA) for a fully remote position. The role involves conducting study monitoring visits, ensuring compliance with protocols and regulations, and supporting various clinical research activities. **

Salary

$80,800.00 - $151,500.00/yr; Bonus, stock and benefits eligibility; Not specified

Skills & Requirements

Must-have

  • Study monitoring visits and reports
  • GCP, protocol, and regulatory adherence
  • Site regulatory document collection
  • Source Data Verification (SDV)
  • Trial Master File (TMF) maintenance
  • Communication with study sites

Nice-to-have

  • Process development and improvement
  • Cross-functional project team participation
  • Diplomacy and respect for others
  • High degree of competence

Key Requirements

  • 5+ years direct clinical research experience
  • Bachelor's degree in biological sciences or medical specialty or higher
  • Experience with EDC and eTMF systems
  • Knowledge of ICH/GCP guidelines
  • Molecular diagnostic, medical device, IVD, companion diagnostics, oncology and/or pathology experience

Work Rights

Not specified

Tailored Resume

Cover Letter