Summary Of Responsibilities
- To complete Other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems and access management.
- Maintain study databases (CTMS, IWRS, EDC, etc.)
- Support study team in e-TMF management activities.
- Support study team in data review and support activities.
- Support in generating the study specific reports.
- Data Review:
- Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks.
- Assist the Lead for any study specific data review related tasks.
- Study Support:
- Generate Study Reports.
- Perform Access management on applicable study systems
- Perform study system set up on recent awarded studies.
- CTMS compliance management.
- Manage project communications.
- Assist project teams for other study support activities.
- Investigator Payments:
- Review EDC, Contract and mark line items “Ready to Pay/Screen Failure” in CTMS.
- Work with PA to generate cover letter or Proforma invoice and payment batch generation in CTMS.
- Perform Invoice QC and Prepare GIA as applicable.
- Coordinate with CTL, PM for line item approvals and GIA approval.
- Process Out of Pocket and Pass Through Expense Invoices.
- Perform payment reconciliation during the study close out or on adhoc request by the study team:
- To follow all applicable departmental Standard Operating Procedures and Work Instructions.
- To complete required trainings according to required timelines.
- To complete day-to-day tasks ensuring quality and productivity.
- To manage project and technical documentation in an appropriate manner.
- To provide administrative and technical support to internal departments and teams as needed.
- To perform checks to ensure quality of work completed.
- To ensure timely escalation and issue resolution as needed.
- To track and report metrics as determined by management according to required timelines.
- To assist with the implementation of revised processes and pro
📌 Central Monitor Assistant (Bengaluru)
🏢 Fortrea
📍 Bengaluru
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