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Initiation Clinical Research Associate II
English
₹15000/MONTH
1 Year
Bachelor's (Preferred)
Work From Office
Date Posted
11-Jul-2026
Location
Karnataka (KA), 1
Job Type
Full Time
Company
Huntsman
Description
Job Title: Clinical Research Associate (CRA) / Site Manager
Location: Bengaluru, Karnataka
Industry: Clinical Research
Employment Type: Full-time
Work Mode: On-site / Field-based
Travel Requirement: Yes (as per project needs)
License Required: Driver’s License (where applicable)
Education Required:
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Bachelor’s degree in Biological Sciences, Pharmacy, or other health-related discipline
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OR equivalent nursing qualification / relevant experience
Key Responsibilities:
Start-Up Phase (Site Identification to Pre-Initiation):
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Serve as the main point of contact for assigned sites during the study start-up phase.
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Build and maintain strong relationships with investigators and site staff.
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Manage feasibility, pre-qualification, and qualification activities including:
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Confidentiality Agreements (CDA)
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Clinical Site Agreements (CSA)
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Remote Qualification Visits (QV)
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Handle country/site-specific documentation, including regulatory submissions (IRB/IEC, MoH/RA).
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Customize, review, and negotiate informed consent forms (ICF).
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Submit necessary documents to Trial Master File (TMF) and update Clinical Trial Management Systems (CTMS).
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Develop and monitor strategies for IRB/IEC approvals, site activation, and patient recruitment.
Maintenance Phase (Initiation to Close-Out):
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Act as Parexel’s point of contact for assigned sites to ensure protocol adherence and issue resolution.
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Conduct and support site training and system access for compliance.
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Manage on-site staff assignments and resolve documentation or operational deficiencies.
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Perform and document on-site/remote visits, including Qualification and Initiation Visits.
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Ensure timely CRF entry, SAE reporting, and patient recruitment updates.
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Evaluate site performance, provide strategies for improvement, and handle payments and drug accountability.
Overall Accountabilities (Throughout the Study Lifecycle):
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Ensure project timelines, compliance with ICH-GCP, SOPs, and local/international regulations.
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Regularly update TMF, CTMS, EDC, IVRS, and other platforms with high-quality documentation.
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Ensure audit/inspection readiness of assigned sites.
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Collaborate cross-functionally to resolve site-specific or regulatory challenges.
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Support administrative functions and provide guidance to support teams when necessary.
Required Skills & Competencies:
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Strong interpersonal, verbal, and written communication skills.
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Client-focused with a flexible, proactive approach.
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Advanced problem-solving and decision-making abilities.
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Excellent organizational and time management skills.
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Experience using CTMS, EDMS, MS Office, and clinical systems.
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Ability to work in a virtual, matrix, and multicultural environment.
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Presentation and consulting skills with attention to detail.
Preferred Experience:
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Prior experience in site management or equivalent clinical research environment.
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Solid understanding of clinical trials methodology and regulatory terminology.
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