Clinical Research Associate

A proactive and detail-oriented Clinical Research Associate (CRA) responsible for overseeing, monitoring, and managing clinical trials across multiple sites to ensure strict adherence to study protocols, regulatory guidelines, and ethical standards. The CRA plays a pivotal role in safeguarding data integrity, patient safety, and overall study quality throughout the clinical trial lifecycle.

In this role, the CRA will collaborate closely with investigators, site staff, sponsors, and cross-functional teams to ensure smooth study execution, timely patient enrollment, and accurate data collection. They will be responsible for conducting site visits, identifying risks, resolving issues proactively, and ensuring compliance with ICH-GCP and applicable regulatory requirements.

Responsibilities:

Monitor clinical trial sites to ensure adherence to protocols, SOPs, and regulatory requirements.

Conduct site initiation, monitoring, and close-out visits.

Review and verify clinical data for accuracy, completeness, and consistency.

Ensure compliance with ICH-GCP, regulatory guidelines, and company standards.

Coordinate with investigators, site staff, and cross-functional teams.

Identify and resolve site issues, escalating when necessary.

Maintain essential documents such as Trial Master Files (TMF).

Track study progress, timelines, and deliverables.

Provide training and support to site staff when required.

Required Skills

Strong knowledge of clinical research processes and regulations

Excellent communication, organizational, and problem-solving skills.

Ability to manage multiple sites and meet deadlines.

Experience: 2–8 Years

Qualifications:

Msc/M.pharma