Job Description

• To ensure all assigned studies follows SOPs, GCP and applicable regulations
•  To do all regulatory/ethics submission as per timelines and to ensure regulatory documents are available, complete and current
•  In coordination with the project manager and/or medical monitor, perform study site selection visits. Participate in/conduct investigator’s meeting and site initiation visits
•  To perform regular monitoring visits to site
• To verify the case report forms and source data according to the monitoring plan
• To ensure site level metrics (i.e. 100% IP accountability, 100% informed consent documentation etc.) are tracked and communicated as appropriate
• Conduct site close out and assure appropriate archival of controlled documents  
• Resolve issues as they affect clinical plan timelines and quality to ensure achievement of goals and objectives at the site level
• Work in liaison with the finance department in the organization and administration of financial payments to the investigators or relevant local institutions
• To ensure the compliance to ICH-GCP guidelines, local & international   regulations (Ex. DCGI, FDA) and applicable SOP

Qualifications

•            M.Pharm pharmacology / B.Pharm+M.Sc. in Clinical Research

•            Should have 2-3 Years’ experience of monitoring clinical trials.

•            Experience in monitoring the clinical trials which includes SIV, SMV, SCV & Site selection visit

•            Travelling included (10-15 days in a month) across India to various cities

Apply : https://careers.teva/job/Navi-Mumbai-Clinical-Research-Assoc-I-400706/1021662900/