In general, it provides site monitoring and
management services on DUA/RWE/PMS studies within MAO function and coordinate
the operational budget and resources across multiple tasks to ensure that studies
conduction meets performance targets and results.
- Arranging Site/Investigator Selection visit to assess
the eligibility of the site.
- Support on EC submission and approval before any
study activities.
- Acting as primary company contact for
assigned trial sites, engaging with Investigator and Site Staff throughout study
period. (Investigator meetings, site visits, study progress, issues/resolutions,
etc.).
- Proper training and communication to ensure
the study procedure and data collection requirement are well understood.
- Discussion of the recruitment plan and
study timeline with PI and site personnel to get alignment with targeted goal.
- Oversight of site study supplies and drugs/device/biologic
supplies to ensure the proper handling, storage and return with accurate
inventory and dispense records.
- ISF maintenance and ensuring secured
storage on site.
- Ensuring the data collection and query
resolution in a timely manner.
- Ensuring safety events are well documented
and timely reported per protocol requirement.
- Reporting of site progress
regularly and working with project leader on issues found on site in time and
providing updates until the issues are well resolved.
Metrics/KPIs: Metrics/KPIs governing these services are
based on the feedbacks from service- related stakeholders and project leaders.
Education and Experience Requirements:
· A minimum of a BA/BS degree, major in
Medicine/Nursing/Biomedicine are preferred.
· 1-2 years of relevant experience.
· Able to work effectively with all levels of the organization.
· Teamwork and collaboration
· Fluent in English reading and writing.
· Skillful at organizing and coordinating.
· Willingness to travel with overnight stay away from
home.
· Good time management skill.
· Good problem-solving skills and initiatives.
· Good computer skill (Word, Excel, Outlook, PowerPoint).
· Attention to detail.