Sr. Project Coordinator II - FSP

Fortrea's FSP team is hiring experienced Sr. Project Coordinators with prior CRO experience! 3 years of PC experience preferred. Oncology experience highly desired. Ability to work some West Coast hours is ideal.

Job Overview:

Coordinates the activities associated with the evaluation, initiation, and management of clinical trials. Manages clinical studies, including CRO oversight. Coordinates the training of staff involved in trial management. coordinates day-to-day operational execution of clinical trials including the daily management activities relating to the Trial Master Files (TMF), including ensuring regulatory inspection-readiness and compliance with applicable laws and regulations. This role also supports the filing, quality control and management of expected documents in eTMF.

Summary of Responsibilities:

• Develop plans to manage clinical trials, determine operational risks and develop and mitigation plans to address risks proactively
• Perform CRO oversight activities such as Trip Report Review, TMF review and co-monitoring visits, per Study Plans. Provide written documentation of all activities including issues and findings in Spreadsheets or databases
• Knowledge of the TMF Reference Model in order to utilize the TMF Master Index as the source of reference for filing documents in eTMF
• Responsible for ensuring any missing documents in eTMF are addressed and reconciled if necessary
• Co-monitor clinical study sites; write and review reports for PSSVs, SIVs, IMVs, and COVs as required
• Assist in the management of external vendors (e.g. clinical labs, study assessment labs)
• Responsible for study start- up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, regulatory documents, and CRO TMF catalog); track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, CRO TMF catalog
• Maintain internal document management system (e.g. Livelink) and TMF ensuring important documents and communication filed timely and appropriately
• Assist with protocol- and study-specific training with vendor(s), site personnel and clinical sites
• Review template informed consents and monitoring visit reports for completeness and accuracy and adherence to the protocol
• Coordinate clinical drug / supply reconciliation with oversight of site and CRA reconciliation
• May conduct data listing review of CRF data for safety, thoroughness, and data preparation for final study reports
• Review and/or create study document (e.g. newsletters, worksheets, study trackers)
• Assist in the coordination of study team management meetings, prepare agenda, draft 2 and finalize minutes and track action items to completion
• Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation
• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures

Qualifications (Minimum Required):

• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from appropriately accredited institution
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements

Experience (Minimum Required):

• 4-5 years of relevant clinical research experience in a pharmaceutical company/CRO.
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
• Ability to develop accurate study related documents with minimal supervision.
• Good verbal and written communication skills.
• Ability to mentor junior staff.
• Ability to resolve project-related problems and prioritize workload for self.
• Demonstrated organizational skills and the ability to prioritize multi-tasks.
• Ability to work with financial information.
• Basic knowledge of project management processes
• Up to 25% travel

Learn more about our EEO & Accommodations request here.