Clinical Research Coordinator

Designation: Clinical Research Coordinator (CRC)

Location: Gurugram (Medanta)

Reporting To: Principal Investigator / Clinical Research Manager

About The Role

We are looking for a detail-oriented and proactive Clinical Research Coordinator (CRC) to support the successful execution of clinical trials while ensuring compliance with regulatory requirements, study protocols, and Good Clinical Practice (GCP) guidelines. The ideal candidate will coordinate study activities, maintain accurate documentation, collaborate with investigators and sponsors, and ensure the highest standards of participant safety and data integrity throughout the clinical research process.

Key Responsibilities

• Coordinate and conduct clinical trials in compliance with ICH-GCP guidelines, approved study protocols, SOPs, and applicable regulatory requirements.
• Support study start-up activities, including site preparation, participant recruitment, screening, enrolment, follow-up, and retention.
• Maintain complete and accurate study documentation, including source documents, Case Report Forms (CRFs), study logs, Site Master File (SMF), and Investigator Site File (ISF).
• Manage Investigational Product (IP) accountability, including receipt, storage, dispensing, reconciliation, shipment, and documentation.
• Coordinate submissions, approvals, amendments, and ongoing correspondence with the Institutional Ethics Committee (IEC).
• Liaise effectively with Principal Investigators, sponsors, Clinical Research Associates (CRAs), Project Managers, and other stakeholders to ensure smooth study execution.
• Support site monitoring visits, sponsor audits, and regulatory inspections by ensuring documentation readiness and compliance.
• Report protocol deviations, adverse events (AEs), serious adverse events (SAEs), and safety information in accordance with study protocols and regulatory guidelines.
• Ensure participant confidentiality, informed consent compliance, and timely completion of study documentation and close-out activities.
• Perform additional research-related responsibilities assigned by the Principal Investigator or management.

Qualifications & ExperienceEducational Qualification

• Graduate or Postgraduate in Life Sciences (B.Sc., B.Pharm., M.Sc., M.Pharm., MD, or equivalent).
• PG Diploma in Clinical Research is mandatory.

Experience

• 1–2 years of experience in clinical research or clinical trial coordination.

Preferred Qualifications

• Good Clinical Practice (GCP) Certification.
• Experience in clinical trial documentation, regulatory submissions, and site management.
• Working knowledge of ICH-GCP, NDCT Rules, and applicable regulatory guidelines.
• Experience working with Electronic Data Capture (EDC) systems is an added advantage.

Required Skills & Competencies

• Strong understanding of ICH-GCP guidelines and clinical research processes.
• Excellent verbal and written communication skills in English.
• Strong organizational, documentation, and interpersonal skills.
• Ability to manage multiple studies, prioritize tasks, and meet timelines.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
• High attention to detail with strong analytical and problem-solving abilities.
• Demonstrates integrity, professionalism, confidentiality, and ethical conduct.
• Adaptable, collaborative, and capable of working effectively in a multidisciplinary research environment.

Skills: clinical trials,research,documentation,clinical research