Clinical Research Associate

ClinSmart; Remote; USD 70,000 - 90,000; Full time

Job summary

A clinical research organization is seeking a Clinical Research Associate (CRA) to evaluate and train investigators and monitor clinical trials remotely. Candidates should have a BS/BA in Life Science or Nursing and a minimum of 3 years of experience in the pharmaceutical or biotechnology industry. Strong knowledge of FDA regulations and GCP guidelines is required, along with excellent communication skills. This role offers flexibility in contract, full-time, or part-time capacity.

Qualifications

• 3+ years CRA experience in pharmaceutical/biotech.
• Extensive knowledge of FDA regulations and GCP.
• Computer proficiency with EDC.

Responsibilities

• Evaluate and train site investigators.
• Conduct site monitoring and ensure compliance.
• Perform other related duties as needed.

Skills

FDA regulations knowledge

EDC experience

Detail oriented

Verbal and written communication skills

Independent working ability

Issue identification

Education

BS/BA in Life Science or Nursing

Job description

Clinical Research Associate job at ClinSmart. Newtown, PA.

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.