Parexel is a leading global clinical research organization (CRO) committed to improving the world’s health through innovative clinical trials, regulatory consulting, and market access solutions. With a strong focus on patient-centric research, Parexel ensures that every clinical development solution is backed by expertise, empathy, and a commitment to making a difference.
At Parexel, employees take pride in contributing to life-changing therapies, working with a shared goal of advancing medical research and patient care.
Job Description: Clinical Research Associate II
As a Clinical Research Associate II (CRA II) at Parexel, you will serve as the primary point of contact for clinical trial sites, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You will oversee site performance from initiation to close-out, managing quality, patient recruitment, and data integrity.
Key Responsibilities
✔ Site Management & Compliance:
- Act as Parexel’s direct liaison with clinical trial sites, ensuring adherence to study protocols and regulatory standards.
- Conduct on-site and remote monitoring visits (Qualification, Initiation, and Close-out visits).
- Evaluate site performance, identify risks, and implement corrective actions.
✔ Patient Recruitment & Data Integrity:
- Develop and optimize patient recruitment strategies in collaboration with site staff.
- Monitor data quality, resolve discrepancies, and ensure timely query resolution.
✔ Regulatory & Documentation Oversight:
- Maintain essential documents in the Trial Master File (TMF) and ensure audit/inspection readiness.
- Review and approve site regulatory documents, including IRB submissions (where applicable).
✔ Stakeholder Communication:
- Build strong relationships with investigators and site staff.
- Provide training and support to site personnel on study procedures and compliance.
✔ Project Coordination:
- Update Clinical Trial Management Systems (CTMS) and track study milestones.
- Collaborate with cross-functional teams to meet project timelines and deliverables.
Skills & Qualifications
✅ Education:
- Bachelor’s degree in Biological Sciences, Pharmacy, Nursing, or related health discipline.
✅ Experience:
- 1-4 years of experience as a Clinical Research Associate (CRA) or equivalent role in clinical research.
- Strong understanding of ICH-GCP guidelines, clinical trial methodology, and regulatory requirements.
✅ Key Skills:
- Excellent problem-solving and analytical abilities.
- Strong communication (verbal & written) and interpersonal skills.
- Ability to work independently and manage multiple priorities.
- Proficiency in CTMS, EDC, and MS Office (Excel, Word).
- Willingness to travel extensively as per study requirements.
Why Join Parexel?
- Impactful Work: Contribute to groundbreaking clinical trials that improve patient lives.
- Career Growth: Opportunities for professional development in a global CRO.
- Collaborative Culture: Work in a supportive, team-oriented environment.
- Competitive Benefits: Attractive salary, travel allowances, and health benefits.
How to Apply?
