Clinical Research Associate

Opportunities available for both remote and Work from Office (Navi Mumbai)

Multiple openings at various levels

Experience range: 3 to 15 years of experience

Role & responsibilities

• Explores new prospective sites and conducting feasibility survey for the studies. Have adequate sites selected for each study
• Assists CPMs in studying start-up activities, regulatory process and execution of study related agreements. Successful initiation of a study
• Prepares visit reports as per SOPs after each site visit. Releasing site visit reports within the SOP defined timelines
• Maintains ongoing communication with sites to provide information, queries resolution, and review overall progress of clinical trials and adherence to established guidelines. Ensure sites get adequate support while recruiting patients and conducting studies.
• Keeps the CPMs updated with the study status at sites.
• Ensures the correct storage, handling and use of investigational product in accordance with SOPs. Ensure that the IP is stored, used and handled in compliance to SOP.
• 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. Ensure that the study files are maintained adequately by the CTA
• Performs other study related tasks as assigned by Clinical Project managers. Ensures all tasks assigned by the CPM are completed in time

Preferred candidate profile

Education: B. Pharm, M. Pharm, B.Sc, M.Sc, Advanced Diploma in Clinical Research Operations

Experience: 5 to 12 years

Knowledge and Skills:

• Thorough understanding and experience in complete gamut of activities in Clinical Operations including ICH, GCP and various regulatory requirements.
• Should have 3 years of on-site monitoring experience, specifically in phase 2 and 3 of trials.
• Should be willing to travel 15 to 18 days in a month