Clinical Research Associate (Cra)

Clinical Research Associate

Clinical Research Associate (CRA)

Position: Full Time

Location: Remote

Job Duties:

• Perform all duties and responsibilities in adherence to protocols, FDA regulations, ICH/GCP guidelines, and company / client SOPs
• Evaluate and train investigators
• Verify accurate transcription of data from source documentation to CRF/EDC
• Ensure regulatory inspection readiness at assigned clinical sites
• Oversee drug accountability
• Conduct pre-study initiation visits
• Orient site personnel to study protocol and procedures
• Minimal travel may be required, based on study specifications
• Attend investigator meetings
• Perform on-site and remote monitoring activities from study start-up through close-out
• Perform other related duties as needed

Knowledge & Skills:

• Ability to work independently with minimal supervision
• Extensive knowledge of FDA regulations and GCPs
• Computer proficient with EDC experience
• Detail oriented
• Ability to proactively identify issues that may impact enrollment and recruitment timelines
• Excellent verbal and written communication skills

Education and Experience:

• Minimum of 3 years CRA experience within the pharmaceutical or biotechnology industry
• BS/BA in Life Science or Nursing (or equivalent foreign education / experience) required
• This position can be contract, full-time, or part-time.