Senior Clinical Research Associate I

 Posted 21 hours ago
  
 Turkey
  
2-5 years experience
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AI Summary

The Senior CRA manages operational aspects of clinical trials at investigator sites, ensuring quality, compliance, and patient safety from activation to database lock. They serve as the primary liaison between study teams and sites while mentoring junior CRAs and coaching site personnel.

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Are you passionate about advancing clinical research and making a real difference in patients' lives? Parexel is seeking an experienced Clinical Research Associate to join our FSP Clinical Operations team (fully outsourced to work for one of the largest Pharmaceutical company) and play a crucial role in ensuring the success of groundbreaking clinical trials.

This is a remote position for candidates based in Istanbul.

About the Role

As a Senior Clinical Research Associate (SCRA)  you will be at the heart of our clinical operations—serving as the trusted liaison between our study teams and investigator sites. You will oversee the conduct of clinical trials from site activation through database lock, ensuring they meet the highest standards of quality, compliance, and patient safety. This is a role where your expertise directly impacts the integrity of clinical research and the development of life-changing therapies.

Key accountabilities:

  • Lead Site Operations: Manage all operational aspects of clinical trial activities at assigned investigator sites, ensuring timelines and quality deliverables are consistently met
  • Build Strong Partnerships: Serve as the primary point of contact for investigator sites, fostering collaborative relationships with site personnel, study teams, and vendors
  • Ensure Compliance & Safety: Conduct thorough site monitoring activities—both onsite and remote—to maintain protocol compliance and safeguard patient welfare
  • Drive Quality & Resolution: Identify and resolve site issues promptly, develop corrective actions, and support quality event remediation
  • Support Recruitment & Progress: Partner with study teams to facilitate investigator meetings, provide enrollment support, and drive recruitment initiatives
  • Manage Critical Documentation: Submit timely reports, maintain trial master files, track protocol deviations, and monitor clinical supply management
  • Mentor & Develop: May mentor Clinical Research Associates and coach site personnel on protocol requirements and best practices

What We're Looking For

Essential Experience:

  • Minimum 3 years of relevant clinical research site monitoring experience
  • 2+ years of oncology monitoring experience
  • Prior experience in participating in GCP audits
  • Ability to support audit conduct, CAPA development and follow-up
  • Bachelor's degree in life sciences, nursing, pharmacy, medicine, or equivalent professional qualification
  • Extensive knowledge of clinical trial methodologies, ICH/GCP guidelines, and FDA/local regulations
  • Fluency in English and Turkish
  • Valid driver's license and passport; willingness to travel 60-80% within your region
  • Global clinical trial experience
  • Strong understanding of regional/country culture and medical practices

Why You'll Thrive Here

  • Make an Impact: Directly contribute to the development of innovative therapies that improve patient outcomes
  • Grow Your Expertise: Work with cutting-edge clinical research in diverse therapeutic areas
  • Develop Your Skills: Opportunities to mentor others and expand your knowledge of regulatory and operational processes
  • Professional Environment: Join a respected clinical research organization committed to excellence and compliance

What We Offer

Competitive compensation, comprehensive benefits, and the opportunity to work on meaningful clinical research that advances global healthcare.

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