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Clinical Research jobs in Bengaluru, Karnataka

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Clinical Research Coordinator
MS CLINICAL
Bengaluru, Karnataka
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Job details

Pay information not provided
Bengaluru, Karnataka

Full job description

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.
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