Are you passionate about advancing healthcare through clinical research? Parexel, a global leader in clinical development solutions, is hiring a Clinical Research Associate II to join their team in Bengaluru or Mumbai, India. This role offers an exciting opportunity to manage clinical trials, ensure regulatory compliance, and contribute to life-changing therapies. If you’re a proactive professional with a knack for problem-solving and a commitment to patient safety, this clinical research job is your chance to make a difference. Read on to explore the responsibilities, qualifications, benefits, and how to apply for this rewarding position.
Key Responsibilities
As a Clinical Research Associate II at Parexel, you will play a pivotal role in overseeing clinical trials from site identification to close-out. Your responsibilities will include:
- Site Management: Act as the primary point of contact for clinical sites, ensuring compliance with ICH-GCP guidelines, Parexel SOPs, and local regulations.
- Trial Oversight: Monitor study implementation, assess data quality, and resolve site issues through problem-solving and strategic planning.
- Relationship Building: Foster strong relationships with investigators and site staff to support trial success and patient recruitment strategies.
- Documentation and Compliance: Review and approve site documentation, manage Trial Master File (TMF) submissions, and ensure audit readiness.
- Training and Support: Conduct on-site training, evaluate staff performance, and address documentation or communication deficiencies.
- Study Supply Management: Oversee test article/study supply accountability, including destruction or return processes.
- Reporting and Systems: Generate visit/contact reports, update Clinical Trial Management Systems (CTMS), and ensure high-quality data entry.
For studies utilizing Parexel SOPs in Japan, an initiation Clinical Research Associate (iCRA) may handle pre-Site Initiation Visit (SIV) tasks, such as IRB applications and document reviews.
Qualifications
To excel in this clinical research associate job, candidates should meet the following requirements:
- Education: Degree in biological science, pharmacy, or a health-related discipline (preferred), or equivalent nursing qualification/experience.
- Experience: Prior site management or clinical research experience with a strong understanding of clinical trial methodologies and terminology.
- Skills:
- Excellent problem-solving and analytical skills.
- Strong interpersonal, verbal, and written communication skills.
- Proficiency in CTMS, EDMS, and MS Office (Excel, Word).
- Ability to work independently, prioritize tasks, and thrive in a matrix team environment.
- Travel: Willingness to accommodate extensive travel as required by study phases.
- Other: Valid driver’s license (where applicable).
Benefits of Joining Parexel
Working as a Clinical Research Associate II at Parexel comes with a host of benefits, including:
- Impactful Work: Contribute to therapies that improve global health and patient outcomes.
- Career Growth: Gain exposure to diverse clinical trials and develop expertise in a supportive, high-performance culture.
- Flexibility: Remote work option available in Bengaluru, offering a healthy work-life balance.
- Collaborative Environment: Join a team that values empathy, teamwork, and innovation in clinical research.
- Professional Development: Access training and opportunities to become a subject matter expert in clinical trial management.
How to Apply
