Clinical Research Coordinator, Only

Role Overview

The Clinical Research Associate (CRA) is the primary link between the sponsor and the clinical study sites. This role is responsible for monitoring clinical trials to ensure the safety of participants and the integrity of data. You will be tasked with ensuring site performance, protocol adherence, and regulatory compliance throughout the lifecycle of clinical studies.

Key Responsibilities

• Conduct Pre-study, Initiation, Routine Monitoring, and Close-out visits to ensure protocol compliance.
• Perform Source Data Verification (SDV) to ensure trial data is accurate, complete, and verifiable.
• Provide guidance to study coordinators and investigators on study procedures and GCP requirements.
• Ensure that all Essential Documents are maintained in the Investigator Site File (ISF) and are audit-ready.
• Ensure all Serious Adverse Events (SAEs) are reported within the mandated timelines.
• Monitor patient recruitment and retention to ensure study milestones are met without compromising safety.
• Oversee the accountability, storage, and dispensing of Investigational Product (IP) at the site.

Requirements & Tech Stack

• Solid understanding of ICH-GCP, local regulatory requirements (CDSCO), and clinical trial protocols.
• Ability to travel frequently to various clinical trial sites.
• Strong critical thinking and problem-solving skills for site-related issues.
• Excellent interpersonal and communication skills to build professional relationships with investigators.
• Proficiency in Clinical Trial Management Systems (CTMS) and EDC software.
• High level of ethics and professional integrity.

Qualifications

• B.Pharm / M.Pharm or Pharm.D.
• B.Sc / M.Sc in Life Sciences (Biotechnology, Microbiology, Biochemistry).
• BDS / BHMS / BAMS / MBBS.
• Advanced Certification in Clinical Research/Clinical Data Management is highly preferred.