Parexel Hiring Initiation Clinical Research Associate | Apply Now in Bengaluru

Parexel Hiring Initiation Clinical Research Associate II – Apply Now!

Are you an experienced Clinical Research professional looking for an exciting career opportunity? Parexel is hiring Initiation Clinical Research Associate II in Bengaluru, India. This is your chance to work with a globally recognized clinical research organization and contribute to life-changing medical research. Read on to learn more about the job role, responsibilities, qualifications, and how to apply.

About Parexel

Parexel is a leading global Clinical Research Organization (CRO) that provides innovative solutions in drug development and regulatory affairs. With a strong commitment to excellence, Parexel collaborates with pharmaceutical, biotech, and medical device companies to bring new therapies to patients worldwide.

Job Role: Initiation Clinical Research Associate II

As an Initiation Clinical Research Associate II (CRA II) at Parexel, you will be responsible for conducting site initiation activities, ensuring compliance with regulatory guidelines, and managing clinical trial sites effectively. Your key focus will be site identification, pre-initiation, activation, and ongoing maintenance of clinical trials.

Key Responsibilities

Start-up Phase (Site Identification to Pre-Initiation)

• Act as Parexel’s primary point of contact for assigned sites.
• Develop and maintain strong relationships with investigators and site staff.
• Conduct country-specific feasibility and site qualification activities.
• Prepare, negotiate, and finalize Clinical Site Agreements (CSAs) and Confidentiality Agreements (CDA).
• Generate site visit reports and identify potential site issues for resolution.
• Assist with the preparation and submission of Institutional Review Board (IRB)/Ethics Committee (EC) applications.
• Ensure timely and high-quality site document collection, review, and approval.

Site Activation & Maintenance

• Monitor and track site activation progress.
• Provide guidance on regulatory document submissions and approvals.
• Conduct site training and ensure compliance with Good Clinical Practice (GCP) guidelines.
• Assist in patient recruitment and retention strategies.
• Support investigator meetings, audits, and regulatory inspections.
• Manage clinical trial management systems (CTMS) and ensure data accuracy.

Site Monitoring & Close-Out

• Perform site visits, generate reports, and track site compliance.
• Address and resolve site issues related to documentation, training, or data quality.
• Ensure that sites remain audit- and inspection-ready throughout the study lifecycle.
• Oversee site payments, protocol adherence, and study-related supplies.
• Conduct final site closure visits and documentation.

Qualifications & Experience Required

Education Background

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Biochemistry, or a related field.

Experience Required

• Minimum 2+ years of experience in Clinical Research, Site Monitoring, or Study Start-up Activities.
• Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Proficiency in Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office tools.

Key Skills & Competencies

• Strong communication and organizational skills.
• Detail-oriented with excellent problem-solving abilities.
• Ability to work independently and within a cross-functional team.
• Willingness to travel as per project requirements.

How to Apply?

Interested candidates can apply online through the Parexel Careers page or submit their applications via the link below:

Apply Now

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Enhance your career with Parexel and make a difference in clinical research today!