Job Title: Initiation Clinical Research Associate II
Location: Bengaluru, India
Employer: Parexel
Job Type: On-site
Category: Clinical Research
About Parexel:
Parexel is a leading global biopharmaceutical services organization that specializes in providing comprehensive services across the clinical trial lifecycle. The company works on innovative treatments, focusing on the well-being and safety of patients. Parexel has been shaping the future of medicine through their expertise and collaboration in clinical trials.
Position Overview:
As an Initiation Clinical Research Associate II (CRA II) at Parexel, you will be responsible for supporting the start-up phase of clinical trials. Your role includes site management, ensuring protocol adherence, and overseeing the quality of site data and documentation. You'll be involved in initiating and maintaining relationships with clinical trial sites and investigators, ensuring compliance and facilitating smooth operations throughout the study.
Key Responsibilities:
Start-Up Phase:
Site Management: Be the point of contact with assigned sites during the start-up phase, ensuring high-quality execution.
Document Preparation & Negotiation: Oversee and facilitate the preparation, negotiation, and execution of essential regulatory documents like Clinical Site Agreements (CSAs) and Confidentiality Agreements (CDA).
Feasibility & Qualification: Manage country-specific feasibility and qualification activities for sites.
Regulatory Submissions: Prepare and submit IRB/IEC applications and ensure proper documentation is submitted for regulatory approval.
Study Maintenance:
Protocol Adherence: Act as the main contact between Parexel and clinical sites to ensure compliance with study protocols.
Training & Monitoring: Provide on-site and remote training to site staff and ensure adherence to project-specific training requirements.
Issue Resolution: Use judgment and experience to resolve site issues related to data quality, recruitment strategies, or study non-compliance.
General Responsibilities:
Documentation & Reporting: Regularly update Clinical Trial Management Systems (CTMS) and submit accurate site-related data to the Trial Master File (TMF).
Site Monitoring: Perform on-site visits to evaluate recruitment plans, study progress, and resolve any issues.
Collaboration & Communication: Participate in internal and external meetings to discuss study progress and site performance.
Key Skills & Experience:
Problem-Solving: Strong ability to identify and resolve issues proactively.
Project Management: Ability to prioritize tasks and meet deadlines while ensuring study quality.
Communication: Excellent interpersonal skills, both verbal and written, for interacting with clients and site staff.
Clinical Research Knowledge: Understanding of clinical trial methodology, ICH-GCP guidelines, and regulatory compliance.
Education & Qualifications:
Degree in a related field (biological sciences, pharmacy, nursing, etc.).
Experience: At least 2-3 years of clinical research or site management experience.
Certifications: ICH-GCP knowledge and relevant certifications are advantageous.
Why Parexel?
At Parexel, Clinical Research Associates (CRAs) have a wide variety of career growth opportunities, whether advancing in technical roles, management, or transitioning into other areas of the business. With a patient-focused and inclusive environment, Parexel promotes collaboration, career development, and work-life flexibility.
Career Path Potential:
CRA I → CRA II → Senior CRA → Project Management → Subject Matter Expert → People Management
Why This Role?
Career Growth: Excellent opportunities for personal and professional development.
Global Exposure: Work with diverse therapeutic areas and cross-functional teams.
Impact: Contribute directly to the success of clinical trials and the well-being of patients.
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