Clinical Research Coordinator

Job Summary

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

1. Study Coordination

• Assist in planning, initiation, and coordination of clinical trials under the supervision of the Principal Investigator.
• Ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.

2. 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.

3. Participant Recruitment and Screening

• Identify and screen eligible study participants.
• Maintain accurate screening and enrollment logs.

4. Informed Consent Process

• Facilitate and document the informed consent process in compliance with regulatory standards.

5. Data Collection and Management

• Accurately collect, record, and maintain study data.
• Perform routine data quality checks and validations.

6. Site Management

• Coordinate with investigative sites and internal teams for smooth study execution.
• Assist in regulatory document preparation and submissions.

7. Safety Reporting

• Monitor, document, and report adverse events as per regulatory guidelines.
• Support participant safety oversight in collaboration with the study team.

8. 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:

• Strong organizational and multitasking abilities.
• Excellent communication and interpersonal skills.
• High attention to detail and accuracy.
• Good understanding of GCP and regulatory requirements.