Research Associate

About the role

Travel to site and monitor the clinical trial data generated at sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followed.

Responsibilities

• Take lead on study activities and perform co-monitoring visits with CRAs to support and guide them as per the requirements.
• Prepare site visit reports within timelines.
• Ensure that site staff is qualified, experienced, and adequately trained to perform their role and responsibilities.
• Ensure study data collected is accurate and verifiable.
• Manage clinical trial site payments and handle any ongoing negotiations.
• Ensure that the site has acceptable infrastructure and that it continues to remain so throughout the study.
• Act as a mentor to site staff and provide continuous support and guidance as required.
• Ensure study documents are appropriately maintained in their respective files till archival.
• Adhere to protocol, regulatory requirements, good clinical practice, and standard operating procedures.
• Assess the trial site and applicable personnel on an ongoing basis.
• Ensure compliance with the patient-consent process and other study procedures.
• Verify the receipt, handling, accounting, storage conditions, and availability of clinical trial material.
• Verify compliance and quality of collected study data.
• Ensure compliance with the procedures to apply in the event of serious adverse events.
• Prepare an appropriate intervention plan to avoid redundant errors and deviations.
• Verify investigator site files and ensure they are consistent with in-house files.
• Perform any other assigned tasks or activities as per the need of the study and organization.

Work Experience

4–5 years of monitoring experience in a Sponsor or CRO setting.

Education

Graduation and post-graduation in Pharmacy.

Competencies

• Strategic Agility
• Customer Centricity
• Result Orientation