Centralized Study Spec I

<p><b><span class="emphasis-2">Summary of Responsibilities:</span></b></p><p></p><p></p><p></p><p></p><ul><li>Manage clinical systems.</li><li>Manage study documents and support eTMF management.</li><li>Maintain study databases (CTMS, IWRS, EDC, etc.)</li><li>Track and follow up with CRAs for outstanding issues.</li><li>Support in generating the study specific reports.</li><li>Manage internal/external communications.</li><li>Assist in ensuring training compliance for study teams.</li><li>Assist in study payments (Site and Vendor).</li><li><b>Data Review:</b></li><li>Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks.</li><li>Perform Associate Lead/Lead role for assigned projects.</li><li>Draft and send study specific reports as per the study team instructions.</li><li>Collaborate with DM, Programming team for reports and communication of data related tasks.</li><li>Perform any other data review related tasks as per the project team instructions.</li><li><b>Study Support:</b></li><li>Generate Study Reports and perform analysis.</li><li>Perform Access management on applicable study systems.</li><li>Perform study system set up on new awarded studies.</li><li>CTMS compliance management.</li><li>Manage project communications.</li><li>Assist project teams for other study support activities.</li><li><b>Investigator Payments:</b></li><li>Review EDC, Contract, and mark line items “Ready to Pay/Screen Failure” in CTMS</li><li>Work with PA to generate cover letter or Proforma invoice and payment batch generation in CTMS.</li><li>Perform Invoice QC and Prepare GIA as applicable.</li><li>Coordinate with CTL, PM for line-item approvals and GIA approvals.</li><li>Process Out of Pocket and Pass-Through Expense Invoices.</li><li>Perform payment reconciliation during the study close out or on ad hoc request by the study team.</li><li>Act as a mentor and provide training to new joiners in team.</li><li>Performing quality check of the work delivered by the team as a part of the QC process.</li><li><b>To follow all applicable departmental Standard Operating Procedures and Work Instructions:</b></li><li>To complete required trainings according to required timelines.</li><li>To complete day-to-day tasks ensuring quality and productivity.</li><li>To manage project and technical documentation in an appropriate manner.</li><li>To provide administrative and technical support to internal departments and teams as needed.</li><li>To perform checks to ensure quality of work completed.</li><li>To ensure timely escalation and issue resolution as needed.</li><li>To execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.</li><li>To support implementation of new monitoring tools.</li><li>To track and report metrics as determined by management according to required timelines.</li><li>To proactively identify opportunities for process improvements and support the implementation of process improvement activities.</li><li>To support the implementation of tools internally to enhance deliverables.</li><li>Ability to mentor and train others.</li><li>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.</li><li>To assist in the preparation of new investigator submission packages for site/regulatory submission.</li><li>To support study team for contracts and budgets activities for investigative sites.</li><li>To assist the study start-up teams with tasks required for site start up activities.</li><li>To review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines.</li></ul><p></p><p><b><span class="emphasis-2">Qualifications (Minimum Required):</span></b></p><ul><li>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) and 5-8 years of work.</li><li>Experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.</li><li>Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li></ul><p></p><p><b><span class="emphasis-2">Experience (Minimum Required):</span></b></p><p></p><ul><li>5-8 Years of experience in the job discipline.</li><li>0-5 Years of experience in other professional roles.</li><li><b>Other required work-related experiences:</b></li><li>Demonstrated ability to plan, prioritize, organize, and communicate effectively.</li><li>Demonstrated ability to pay attention to detail.</li><li>Strong interpersonal skills with ability to work well with others.</li><li>Ability to deliver consistent high quality of work.</li><li>Strong interpersonal skills.</li><li>Ability to Influence others.</li><li>Ability to facilitate meetings.</li><li>Ability to lead process improvement initiatives.</li></ul><p></p><p><b><span class="emphasis-2">Preferred Qualifications Include:</span></b></p><ul><li>Candidate should be able to work in shifts if business demands for it.</li><li>May involve extensive use of computer and keyboard.</li></ul><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>