Clinical Research Associate Professional

5 days ago


Malvern, Pennsylvania, United States OCUGEN OPCO INC Full time

Job Title: Clinical Research Associate Professional

About the Job

The Clinical Research Associate Professional is a crucial member of Ocugen's clinical trial management team. This role requires developing strong relationships with clinical sites, CROs, and other stakeholders to ensure successful planning and execution of clinical studies.

Key Responsibilities:

  • Support study management teams to ensure compliance with study protocols, ICH/GCP guidelines, and government regulations.
  • Assist in site feasibility assessments, qualification, and selection.
  • Drive the study start-up process with the CRO, ensuring timely submissions and completion of regulatory documents.
  • Interface with clinical sites for data entry, query resolution, and monitoring visits.
  • Proactively identify risks and develop mitigation plans.
  • Draft or assist in preparing study-related documents and templates.

Qualifications:*

  • Bachelor's degree in life sciences or related field.
  • 3+ years of progressive clinical research experience in biotechnology/pharmaceutical industry.
  • Strong knowledge of GCPs, ICH, and FDA regulatory requirements.
  • Excellent communication and collaboration skills.

Estimated Salary:** $85,000 - $110,000 per year (depending on location and experience)



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