iCRA II (Initiation Clinical Research Associate II)
Company: Parexel
Location: Bengaluru, India
Job Type: Full-Time
Job Requisition ID: R0000036655
Posted: Recently
About Parexel
Parexel is a leading global biopharmaceutical services organization dedicated to improving world health. From clinical trials and regulatory services to consulting and market access, Parexel supports the development of innovative therapies with a patient-first mindset. Every role at Parexel contributes directly to advancing treatments that make a meaningful difference in patients’ lives.
Job Overview
Parexel is seeking an Initiation Clinical Research Associate II (iCRA II) with strong expertise in clinical trial start-up, Pre-SIV, and site activation activities. This role plays a critical part in ensuring timely, compliant, and high-quality site initiation and regulatory readiness across assigned studies.
The iCRA II acts as the primary point of contact for assigned clinical sites during start-up and activation, driving strategy, documentation quality, regulatory submissions, and stakeholder coordination from site identification through activation and maintenance.
Key Responsibilities
Study Start-Up and Site Activation
Serve as Parexel’s primary liaison with assigned clinical sites during start-up and activation phases.
Develop and execute start-up strategies to ensure timely site activation and regulatory approvals.
Build and maintain strong relationships with investigators and site staff.
Support country-specific feasibility, site qualification, and pre-qualification activities, including remote qualification visits when required.
Prepare, review, negotiate, and manage Confidentiality Agreements (CDAs) and related amendments.
Manage and resolve country- and site-level TMF issues, ensuring First Time Quality (FTQ) documentation.
Customize, review, and negotiate country- and site-specific Informed Consent Forms (ICFs), including translations and amendments in line with regulatory and sponsor requirements.
Prepare, submit, and track IRB/IEC, Ministry of Health (MoH), and Regulatory Authority (RA) applications until final approval.
Forecast and manage timelines for regulatory submissions, approvals, and site activation milestones.
Ensure timely and accurate updates in Clinical Trial Management Systems (CTMS) and other trial systems.
Study Maintenance and Ongoing Support
Manage regulatory submissions and amendments throughout the study lifecycle.
Maintain completeness and quality of Trial Master File (TMF) documentation.
Ensure sites remain audit- and inspection-ready at all times.
Support site access to study systems and ensure completion of all required training prior to study start.
Identify, assess, and proactively resolve or escalate risks related to timelines, compliance, training, data quality, or site readiness.
Cross-Functional Collaboration and Compliance
Collaborate effectively with internal teams, sponsors, and external stakeholders.
Ensure compliance with ICH-GCP, local and international regulations, sponsor requirements, and Parexel SOPs.
Participate in internal and external meetings as required by the project or sponsor.
Maintain accurate reporting, metrics, timesheets, and documentation.
Proactively communicate progress, risks, and issues to management.
Required Experience and Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Biological Sciences, or a related healthcare discipline preferred
Nursing qualification or equivalent relevant experience may also be considered
Experience
Minimum 3–5 years of clinical research experience, with substantial hands-on experience in clinical trial start-up and site activation
Strong understanding of clinical trial methodology, regulatory processes, and clinical research terminology
Experience working with global studies and cross-cultural teams preferred
Technical and Professional Skills
Proven experience with CTMS, eTMF, and clinical trial documentation systems
Strong proficiency in MS Word, Excel, and related office tools
Excellent written and verbal communication skills in English
Strong analytical, organizational, and problem-solving abilities
Ability to manage multiple priorities in a fast-paced, matrix environment
High attention to detail with a strong commitment to quality and compliance
Ability to work independently with minimal supervision while maintaining proactive communication
Why Join Parexel
At Parexel, people are at the center of everything we do. You will be part of a global organization that values collaboration, innovation, integrity, and continuous learning. This role offers exposure to complex global studies, professional growth opportunities, and the chance to directly impact patient outcomes worldwide.
Equal Opportunity Statement
Parexel is an equal opportunity employer and is committed to fostering an inclusive, diverse, and respectful workplace.
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