Central Monitor Assistant at FTINDDDBLR Fortrea

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About The Role

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 new 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 procedures.
To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.
To assist in the preparation of new investigator submission packages for site/regulatory submission.
To assist in Investigator Payment Processing.
To assist the study, startup teams with tasks required for site start up activities.
To manage and support assigned studies for upload as per set objectives.
To follow up with study team on uploading queries.
To review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines.
All other duties as needed or assigned.
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Qualifications (Minimum Required)

University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex. Nursing certification, Medical or laboratory technology).
02-03 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Fluent in English, both written and verbal.