About this 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. • Manage study documents and support eTMF management. • Maintain study databases (CTMS, IWRS, EDC, etc.) • Support study team in data review and support activities. • Track and follow up with CRAs for outstanding issues. • Support in generating the study specific reports. • Manage internal/external communications. • Assist in ensuring training compliance for study teams. • Manage study payments (Site and Vendor). • 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. • Draft and send study specific reports as per the study team instructions. • Perform any other data review related tasks as per the project team instructions. • Document Review: • Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial. • Review amended Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. • File amended Informed Consent Form and Investigator Package approval documentation in TMF and eTMF. • Review Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight. • Study Support: • Generate Study Reports and perform analysis. • 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 approvals. • Process Out of Pocket and Pass-Through Expense Invoices. • Perform payment reconciliation during the study close out or on ad hoc 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 participate in process improvement opportunities and 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, Site budget validation and related activities. • To assist the study start up teams with tasks required for site start up activities. • 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.
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). • 03-05 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.
Experience (Minimum Required):
• 03-05 Years of experience in the job discipline. • 00-02 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.
Physical Demands/Work Environment:
• General Office Environment.
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