Are you a seasoned clinical research professional looking for an exciting opportunity to make a difference in global healthcare? Parexel, a leading global biopharmaceutical services organization, is hiring for the position of Senior Clinical Research Associate (CRA). This remote role based in Bengaluru, India, offers you the chance to contribute to cutting-edge clinical trials and improve patient outcomes worldwide. If you have a passion for clinical research and a commitment to excellence, this could be the perfect role for you.
About Parexel
At Parexel, we are driven by a shared mission to improve global health. From clinical trials to regulatory consulting, every solution we provide is rooted in our deep conviction to make a difference. Each team member plays a vital role in developing therapies that benefit patients, and we take our work personally, ensuring empathy and dedication in everything we do.
Key Responsibilities
As a Senior Clinical Research Associate, you will be responsible for managing clinical trial sites from start-up through close-out. Your key accountabilities will include:
- Start-Up Phase:
- Act as the primary point of contact for assigned sites, ensuring quality and delivery during the start-up phase.
- Build strong relationships with investigators and site staff.
- Conduct feasibility studies, site qualification visits, and negotiate clinical site agreements.
- Prepare and submit regulatory documents, including IRB/IEC and MoH/RA applications.
- Develop strategies for site activation and patient recruitment.
- Maintenance Phase:
- Monitor site compliance with study protocols and regulatory requirements.
- Conduct on-site and remote visits, including qualification, initiation, and monitoring visits.
- Address site-related issues, including data quality, training deficiencies, and protocol non-compliance.
- Ensure timely and accurate documentation in Clinical Trial Management Systems (CTMS).
- Close-Out Phase:
- Evaluate site performance and ensure all study-related activities are completed.
- Manage study supplies, site payments, and regulatory documentation.
- Prepare sites for audits and regulatory inspections.
Skills and Qualifications
To excel in this role, you will need:
- Experience: Substantial site management or clinical research experience, with a strong understanding of clinical trial methodology and terminology.
- Education: A degree in biological sciences, pharmacy, or a related field (or equivalent experience).
- Skills:
- Strong problem-solving and decision-making abilities.
- Excellent communication and interpersonal skills.
- Proficiency in Clinical Trial Management Systems (CTMS) and MS Office.
- Ability to work independently and in a team environment.
- Attention to detail and a commitment to high-quality work.
Why Join Parexel?
- Impactful Work: Contribute to the development of therapies that improve patient lives.
- Professional Growth: Opportunities for mentorship, skill development, and career advancement.
- Global Collaboration: Work in a diverse, matrixed environment with teams across the globe.
- Work-Life Balance: Enjoy the flexibility of a remote work arrangement.
