Start-up Associate

Job Description

This role is for upcoming future opportunities that may arise at Fortrea. Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer. Summary of Responsibilities: • Provide training, utilization, development, and performance review of assigned staff. • Lead development of start-up processes. • Serve as lead for site related start-up activities, as applicable, during study start-up phase. • May present at external and/or internal meetings including, but not limited to BID Defense, Client Kick Off Meetings. • Understand client expectations and project specifications to forecast timelines of study startup (up to certain point). Communication of timelines with project managers for projects conducted in the US and UK. • Coordinate with GCD start-up, when contracted in support of CPS studies where required (i.e., understand project requirements, secure resources, monitor progress of GCD project team members). • Ensure that all start-up staff allocated to assigned project(s) adhere to professional standards and SOPs. • Participate in identifying SOPs for training matrix for start-up staff. Schedule/conduct training as applicable. • Interpret billing guidelines for functional area and train start up team accordingly. • Ensure direct reports are trained in the study budgeting process and assist PM in communicating with sites as appropriate. Assist PM and PC with Investigator Grants Estimate (IGE) to ensure estimate reflects the scope of the project. • Review and provide input to relative functions areas, for the development of core study documents; oversee Investigator Package compilation. • Adheres to parameters to Start-up plans. • Oversee IRB/EC/HRA/CA submissions (including amendments as applicable) and approval status (except for Fortrea US CRU studies). Coordinate addressing queries ensuring required timelines are met. • Oversee/negotiate NIHR/NHS costing tool templates as applicable. Coordinate queries/updates ensuring required timelines are met. • Coordinate PIC site activities as required. • Support inspections, internal and client audits. Support resolution of inspection/audit findings for start-up functions. • Collate and distribute essential study related documents to regional start-up staff inclusive of all Investigator Package Plan documents, patient facing materials, and any additional documents as required for a project. • Oversee/set up and distribute regulatory binders as applicable for the study. • Oversee Green Light approval regionally and globally. Alert PM of any risks. • Establish working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business. • Responsible for appropriate issue escalation per Fortrea quality SOPs. • Manage and report on client project metrics for start-up expectations and deliverables. • Work with clinical monitoring project team members to ensure accuracy and completion of all study documents. • Timely and accurate document reviews prior to finalization. • Direct contact with variety sites, investigator sites, commercial CROs and academic. • Contributes updates on investigator sites for internal metrics. • All other duties as needed or assigned. Show More