Clinical Research Associate

Position Details:

Designation: Clinical Research Associate

Business Unit: Research & Development

Location: Mahape, Navi Mumbai.

Role overview:

To manage clinical projects with specific focus on technical and operational coordination (of clinical studies) with study sites, external service providers and internal departments and support clinical trials by identifying potential investigators; conducting pre-trial site visits; training site staff; monitoring trial, drug accountability and other study related activities to ensure compliance with protocol and overall clinical objectives.

Role & responsibilities:

• Explores new prospective sites and conducting feasibility survey for the studies.
• Assists CPMs in studying start-up activities, regulatory process and execution of study related agreements.
• Prepares visit reports as per SOPs after each site visit.
• Maintains ongoing communication with sites to provide information, queries resolution, and review overall progress of clinical trials and adherence to established guidelines.
• Keeps the CPMs updated with the study status at sites.
• Ensures the correct storage, handling and use of investigational product in accordance with SOPs.
• Supervises the CTA in maintaining and updating trial master files on regular basis; Responsible for ensuring compliance to GCP, applicable SOPs and applicable regulatory requirements.
• Performs other study related tasks as assigned by Clinical Project managers

Educational Qualifications:

B.Pharm/M.Pharm/M.Sc

Advanced Diploma in Clinical Research Operations

Experience:

Interested candidates with relevant experience can apply.