Job Opportunities API

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