Sr. Cra

Ivivamedical

**
Gcp and ich guidelines
Subject recruitment planning
Protocol and study training
** Ivivamedical is seeking a Senior Clinical Research Associate (Sr. CRA) to oversee site monitoring and management to ensure compliance with study protocols and regulations. The ideal candidate will have at least two years of on-site monitoring experience and strong organizational and communication skills. **

Job Summary

  • 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.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

Matching Summary

Match Score: 75

** Ivivamedical is seeking a Senior Clinical Research Associate (Sr. CRA) to oversee site monitoring and management to ensure compliance with study protocols and regulations. The ideal candidate will have at least two years of on-site monitoring experience and strong organizational and communication skills. **

Skills & Requirements

Must-have

  • GCP and ICH guidelines
  • Subject recruitment planning
  • Protocol and study training
  • Site quality and integrity evaluation
  • Trial Master File (TMF) documentation

Nice-to-have

  • Effective time and financial management
  • Establish working relationships

Key Requirements

  • At least 2 years of on-site monitoring experience
  • High School Diploma or equivalent
  • Degree in scientific discipline or health care preferred
  • Good knowledge of applicable clinical research regulatory requirements
  • Computer skills including Microsoft Word, Excel and PowerPoint

Work Rights

Not specified

Tailored Resume

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