1.? Be responsible for the delivery of the studies at allocated sites and works in close collaboration with other CRAs and the local study delivery team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.
2.? Conduct site feasibility assessment.
3.? Contribute to the selection of potential investigators and leading investigator.
4.? Contribute to national Investigator meeting.
5.? Obtain and maintain essential documentation in compliance with GCP, ICH-GCP, Company documents and local regulations both in the office and at site.
6.? Actively participate in local Study Team meetings.
7.? Train, support and advice Investigators and site staff in study related matters.
8.? Initiate, monitor and close study sites in compliance with Company Documents. Share information on patient recruitment and study site progress within local Study Team.
9.? Drive performance at the sites.
10. Update study related systems with data from sites per required timelines.
11. Manage study supplies, drug supplies and drug accountability at study sites.
12. Perform source data verification. Proactively identify study-related issues and escalates as appropriate
13. Complete monitoring visit reports within required timelines. Document the issues and follow up with sites until it is resolved.
14. Ensure accurate and timely reporting of Serious Adverse Events.
15. Work with data management to ensure quality of the study data. Ensure data query resolution.
16. Prepare for activities associated with audit and regulatory inspection at responsible sites in liaison with local study team lead and QA.
17. Ensure compliance with company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Education, Qualification, Skills and Experience
1.? University degree in related discipline, preferably in life science, or equivalent qualification.
2.? At least 3 years clinical research working experience in multinational pharmaceutical companies or multinational CROs is preferred.
3.? Fluent knowledge of spoken, read and written English.
4.? Excellent knowledge of international guidelines ICH/GCP.
5.? Good knowledge of relevant local regulations.
6.? Good medical knowledge and basic understanding of the drug development process.
7.? Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
8.? Ability to travel nationally as required.