Job Title: Clinical Research Associate II
Location: Bengaluru, India
Employment Type: Full-Time
Experience Required: 2–5 years in clinical research or site management
Education: Bachelor’s degree in Biological Sciences, Pharmacy, Nursing, or other health-related disciplines
About the Role:
Parexel is seeking a Clinical Research Associate II (CRA II) to manage and oversee clinical trial activities at assigned sites in Bengaluru. As the primary point of contact for clinical sites, the CRA II ensures protocol compliance, site quality, patient safety, and data integrity from site initiation through study close-out. This role involves building strong relationships with investigators and site staff, driving patient recruitment strategies, resolving site issues, and maintaining adherence to ICH-GCP and regulatory standards.
Key Responsibilities:
Site Management and Oversight:
Serve as Parexel’s direct contact with assigned sites, ensuring compliance with study protocols and regulatory requirements.
Build and maintain effective relationships with investigators and site staff.
Facilitate site access to study systems and ensure completion of project-specific training requirements.
Conduct on-site and remote visits, including site qualification, initiation, monitoring, and close-out.
Identify and address site performance issues, providing corrective action plans and follow-up.
Data Management and Documentation:
Monitor site data entry, query resolution, and SAE reporting in Clinical Trial Management Systems (CTMS), EDC, IVRS, and SIS.
Review, approve, and maintain site regulatory documentation and Trial Master File (TMF) compliance.
Assess potential data quality and integrity issues and implement appropriate follow-up.
Ensure study supply management, including accountability and tracking.
Project Support and Collaboration:
Participate in project meetings, audits, and regulatory inspections.
Provide site-specific recommendations to optimize patient recruitment and site performance.
Mentor and support Administrative Support Team members as required.
Update management on project progress, risks, and issue resolution strategies.
Quality and Compliance:
Maintain adherence to ICH-GCP, Parexel SOPs, and applicable local/international regulations.
Ensure sites are audit and inspection ready at all times.
Apply strong problem-solving and consulting skills to address project-related challenges.
Skills and Competencies:
Strong site management and clinical trial knowledge.
Ability to work independently and proactively, with sound problem-solving skills.
Excellent interpersonal, verbal, and written communication skills.
Advanced knowledge of CTMS, EDMS, EDC, and MS Office applications.
Strong analytical and time management abilities, with the ability to prioritize multiple tasks.
Flexibility to work in a matrix environment and across cultures.
Willingness to travel extensively as required by study assignments.
Qualifications:
Bachelor’s degree in Biological Sciences, Pharmacy, Nursing, or related health discipline.
Minimum 2–5 years of site management experience or equivalent in clinical research.
Thorough understanding of clinical trial methodology, regulatory requirements, and terminology.
Knowledge of ICH-GCP and local regulations governing clinical research.
Why Join Parexel:
Work with a global leader in clinical research, contributing to life-changing therapies.
Gain exposure to complex clinical trials and diverse therapeutic areas.
Opportunities for professional growth, training, and career development.
Collaborative, inclusive work culture fostering innovation and excellence.
How to Apply:
Submit your resume to join Parexel’s Clinical Research team in Bengaluru and contribute to advancing patient care and clinical research excellence worldwide.
#Hiring #ClinicalResearchAssociate #CRAJobs #ClinicalTrials #PharmaJobs #Parexel #BengaluruJobs
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