Centralized Study Analyst

Job description

**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. Learn more about our EEO & Accommodations request here.