Position: Full Time
Location: Remote
Job Duties:
Evaluate and train investigators
Attend investigator meetings
Conduct pre-study initiation visits
Orient site personnel to study protocol and procedures
Perform on-site and remote monitoring activities from study start-up through close-out
Verify accurate transcription of data from source documentation to CRF/EDC
Oversee drug accountability
Ensure regulatory inspection readiness at assigned clinical sites
Perform all duties and responsibilities in adherence to protocols, FDA regulations, ICH/GCP guidelines, and company / client SOPs
Minimal travel may be required, based on study specifications
Perform other related duties as needed
Knowledge & Skills:
Extensive knowledge of FDA regulations and GCPs
Computer proficient with EDC experience
Detail oriented
Excellent verbal and written communication skills
Ability to work independently with minimal supervision
Ability to proactively identify issues that may impact enrollment and recruitment timelines
Education and Experience:
BS/BA in Life Science or Nursing (or equivalent foreign education / experience) required
Minimum of 3 years CRA experience within the pharmaceutical or biotechnology industry
This position can be contract, full-time, or part-time.
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