We are seeking enthusiastic and detail-oriented Clinical Research Coordinators with 1–3 years of experience in BA/BE studies. The primary focus of this role will be managing CTRI registrations and Ethics Committee (EC) submissions on a weekly basis, along with supporting overall study coordination activities.
Key Responsibilities
Study Coordination
Assist in planning, initiation, and coordination of clinical trials under the supervision of the Principal Investigator.
Ensure compliance with study protocols, Valuable Clinical Practice (GCP), and regulatory requirements.
CTRI Registration & EC Submissions (Core Responsibility)
Perform and manage CTRI registrations accurately and within timelines.
Prepare, review, and submit Ethics Committee (EC) submissions on a weekly basis.
Maintain all regulatory documentation and ensure timely updates and approvals.
Participant Recruitment and Screening
Identify and screen eligible study participants.
Maintain accurate screening and enrollment logs.
Informed Consent Process
Facilitate and document the informed consent process in compliance with regulatory standards.
Data Collection and Management
Accurately collect, record, and maintain study data.
Perform routine data quality checks and validations.
Site Management
Coordinate with investigative sites and internal teams for smooth study execution.
Assist in regulatory document preparation and submissions.
Safety Reporting
Monitor, document, and report adverse events as per regulatory guidelines.
Support participant safety oversight in collaboration with the study team.
Training and Development
Participate in ongoing training programs.
Stay updated with clinical research regulations and industry trends.
Requirements
Education:
Bachelor’s degree in Life Sciences or a related field.
Experience:
0–3 years of experience in BA/BE studies (mandatory).
Skills:
Robust organizational and multitasking abilities.
Excellent communication and interpersonal skills.
High attention to detail and accuracy.
Positive understanding of GCP and regulatory requirements.
📌 Clinical Research Coordinator Bengaluru (India)
🏢 MS Clinical
📍 India
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