Job Description
- 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.
- Take lead on study activities and perform co-monitoring visits with CRAs to support and guide them as per the requirements.
- Preparing 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 maintain in their respective files till archival
- Adheres to protocol, regulatory requirements, good clinical practice, and standard operating procedures.




- Assesses the trial site and applicable personnel on an ongoing basis.
- Ensures compliance with the patient-consent process and other study procedures.
- Verifies the receipt, handling, accounting, storage conditions, and availability of clinical trial material. Verifies compliance and quality of collected study data.
- Ensures compliance with the procedures to apply in the event of reliable adverse events.
- Prepare an appropriate intervention plan to avoid redundant errors and deviations.
- Verifies investigator site files and ensure it is consistent with in-house files.
- Any other assigned task/activities as per the need of study and organization to be completed.

Work Experience

4-5 years of Monitoirng experience in Sponsor/ CRO setting

Education

Graduation
Post Graduation in Pharmacy

Competencies

1. Strategic Agility
3. Customer Centricity
5. Result Orientation

📌 Research Associate (Pune)
🏢 LUPIN
📍 Pune