Clinical Research Coordinator

MS Clinical Research; Bengaluru; On-site; INR 350,000 - 550,000; Full time

Job summary

MS Clinical Research in Bengaluru is seeking a proactive Clinical Research Coordinator with 1–3 years of BA/BE experience to manage CTRI registrations and EC submissions weekly, and support overall study coordination.

Responsibilities include participant recruitment, data collection, site management, safety reporting, and ensuring compliance with GCP and regulatory standards; the role offers on-site work and exposure to cutting-edge trials.

Qualifications

• Bachelor's degree in Life Sciences or related field is required.
• 0–3 years of experience in BA/BE studies (mandatory).
• Strong organizational, communication, and regulatory knowledge are essential.

Responsibilities

• Study Coordination: plan, initiate, and coordinate clinical trials under PI supervision.
• CTRI Registration & EC Submissions: perform registrations and prepare submissions weekly.
• Participant Recruitment and Screening: identify, screen, and document eligible participants and obtain informed consent.
• Data Collection and Management: accurately collect and maintain study data with quality checks.
• Site Management: coordinate with investigative sites and internal teams for smooth study execution.
• Safety Reporting: monitor, document, and report adverse events per guidelines.
• Training and Development: participate in ongoing training and stay updated on regulations.

Skills

Organizational Skills

Communication Skills

Interpersonal Skills

Attention to detail

GCP Knowledge

Education

Bachelor's degree in Life Sciences or related field

Job description

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.
• 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.

Required Skills

Adaptability Ethical Conduct Accountability Collaboration Time Management