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:
Site Monitoring: Conduct Pre-study, Initiation, Routine Monitoring, and Close-out visits to ensure protocol compliance.
Data Verification: Perform Source Data Verification (SDV) to ensure trial data is accurate, complete, and verifiable.
Site Management: Provide guidance to study coordinators and investigators on study procedures and GCP requirements.
Regulatory Oversight: Ensure that all Essential Documents are maintained in the Investigator Site File (ISF) and are audit-ready.
Adverse Event Reporting: Ensure all Serious Adverse Events (SAEs) are reported within the mandated timelines.
Subject Safety: Monitor patient recruitment and retention to ensure study milestones are met without compromising safety.
Investigational Product (IP): Oversee the accountability, storage, and dispensing of investigational products at the site.
Education Qualification:
- 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.
Required Skills:
- Solid understanding of ICH-GCP, local regulatory requirements (CDSCO), and clinical trial protocols.
- Ability to travel frequently to various clinical trial sites.
- Solid critical thinking and problem-solving skills for site-related issues.
- Excellent interpersonal and communication skills to build qualified relationships with investigators.
- Proficiency in Clinical Trial Management Systems (CTMS) and EDC software.
- High level of ethics and professional integrity.