Role & Responsibility

Conduct site feasibility assessment.

Contribute to the selection of potential investigators and leading investigator.

Contribute to national Investigator meeting.

Obtain and maintain essential documentation in compliance with GCP, ICH-GCP, Company documents and local regulations both in the office and at site.

Actively participate in local Study Team meetings.

Train, support and advice Investigators and site staff in study related matters.

Initiate, monitor and close study sites in compliance with Company Documents. Share information on patient recruitment and study site progress within local Study Team.

Drive performance at the sites.

Update study related systems with data from sites per required timelines.

Manage study supplies, drug supplies and drug accountability at study sites.

Perform source data verification. Proactively identify study-related issues and escalates as appropriate.

Complete monitoring visit reports within required timelines. Document the issues and follow up with sites until it is resolved.

Ensure accurate and timely reporting of Serious Adverse Events.

Work with data management to ensure quality of the study data. Ensure data query resolution.

Prepare for activities associated with audit and regulatory inspection at responsible sites in liaison with local study team lead and QA.

Ensure compliance with company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).