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.

- Positive understanding of GCP and regulatory requirements.

📌 Clinical Research Coordinator (Bengaluru)
🏢 MS Clinical
📍 Bengaluru