Research Associate

Lupin; Pune District; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Lupin is seeking a Clinical Monitoring professional to travel to sites and monitor trial data, ensuring compliance with ICH GCP and study protocols. You will lead co-monitoring visits with CRAs and prepare timely site visit reports, while ensuring staff qualification and data accuracy.

The role requires 4-5 years of monitoring experience in Sponsor/CRO environments and involves mentorship and continuous site support to maintain compliant infrastructure throughout the study.

Qualifications

• 4-5 years of monitoring experience in Sponsor/CRO setting

Responsibilities

• Travel to sites and monitor clinical trial data to ensure ICH GCP, protocol and regulations are followed.
• Lead study activities and co-monitoring visits with CRAs to support and guide them as required.
• Prepare site visit reports within timelines.
• Ensure site staff are qualified, experienced, and adequately trained.
• Verify accuracy and verifiability of study data.
• Manage site payments and ongoing negotiations.
• Ensure site infrastructure remains compliant throughout the study.
• Mentor site staff and provide ongoing support and guidance.
• Maintain study documents in their respective files until archival.
• Adhere to protocol, regulatory requirements, GCP, and SOPs.
• Assess trial site and personnel on an ongoing basis.
• Ensure compliance with patient-consent and other study procedures.
• Verify handling, storage, and availability of clinical trial material and data quality.
• Prepare intervention plans to avoid errors and deviations.
• Verify investigator site files align with in-house files.
• Complete any other assigned tasks as needed.

Skills

Monitoring

ICH-GCP

Trial coordination

Mentoring

Site management

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 serious 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