Essential Functions
- Complete appropriate role-specific training to perform job duties.
- Provide study level administrative support to the clinical study management team, including running system reports, preparing and distributing status reports, creating and maintaining study trackers, and following up on outstanding issues.
- Assist in updating and maintaining systems within project timelines/plans and drive tracking compliance in various systems to enable credible data for analysis.
- Perform activities as per the task list delegated by CMS leads.
- Assist CMs in the preparation of i-site packs for their respective sites and countries for assigned studies by pulling associated reports.
- Perform assigned access management related administrative tasks to support team members with project execution, such as processing access requests and following up with relevant vendors.
- Provide support to the technical solution specialist (TSS) on formulations in Excel and the front-end part.
- Periodically review site-level KRIs and historic site performance according to the Central Monitoring Plan.
- Facilitate early identification of site-level risks/issues during study conduct and identify risks.
- Monitor site performance and make recommendations for timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit).
- Review the effectiveness of recommended actions and take appropriate additional actions if no effect is observed.
- Review the Study Central Monitoring Plan.
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
- Adhere to the key activities outlined in the SOW as per customer requirements.
