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 (Remote) 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
