Central monitor assistant (Fortrea)

Roles and 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.

• Create i Site Pack

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.

Experience (Minimum Required):

• 02-03 Years of experience in the job discipline.

• 00-03 Years of experience in other professional roles.

• Other required work-related experiences:

• Demonstrated ability to organize and communicate effectively.

• Demonstrated ability to pay attention to detail.

• Ability to work well with others.

• Ability to deliver consistent high quality of work.

• Ability to use computer and departmental tools.