Project Manager (Clinical Trials)

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.