Clinical Research Associate Job at ClinSmart, Newtown, PA

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  • ClinSmart
  • Newtown, PA

Job Description

Clinical Research Associate (CRA)

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.

Job Tags

Full time, Contract work, Remote work,

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