Project Coordinator Clinical Pharmacology

Fortrea is one of the world´s largest and longest-established early-phase clinical research organizations. From first-in-human to exploratory biomarker or complex ph1b programs, our Clinical Pharmacology team generate critical safety, tolerability, PK and PD data that help new medicines to move forward

Fortrea Clinical Pharmacology is hiring Clinical Project Coordinators in the UK, to drive this mission forward. Candidates with strong organizational skills, attention to details, and the ability to manage financial processes effectively will be particularly well suited for the role.

There are several roles in consideration, to work more sponsor dedicated or full service CPS and at different levels of seniority.

Job Overview:

Responsible for the coordination and completion of project tasks in support of Project Management for low to medium complex studies including external site studies. Initiates creation of study specific documents (e.g., Project Management Plan, Communication Plan, Risk Mitigation Plan). Develops trial management tools to monitor study activity, including project setup activities, formats, posts, and compiles study timelines. Attends, schedules, and organizes study-related meetings; distributes agendas, maintains, and distributes meeting minutes, Project, and Risk Log. Works with the document specialist team as appropriate to transfer documents in a timely manner to the Trial Master File (TMF) in accordance with applicable SOPs, policies, system, and client requirements. Assists with training and mentoring new PCs and Associate PCs.

Summary of Responsibilities:

• Works independently with little assistance from a more senior PC or PM in owning and developing study specific documents (e.g., Project Management Plan, Communication Plan, Investigator Package Plan, Risk Register, Project Specific Training Matrix, and any other applicable plans as required), including compliance with client-specific requirements, for low to medium complex studies including external site studies. Distributes them to the study team and/or sponsor for review, compiles comments, makes updates with minimal assistance and routes final documents. Proactively monitors training compliance of the study team and updates the training matrix as required.
• Maintains an internal standardized filing structure for study related documents; proactively maintains documents within the filing structure and suggests changes as necessary to maintain organized files.
• Responsible for project setup activities (e.g., study ID request, SAS Environment Setup request, eTMF, Study-specific Distribution Lists, etc.).
• Manages the setup and updating of CTMS. Attains local country project expertise for CTMS reporting, study metrics, risk management regarding communication, coordination, and eTMF quality.
• Independently organizes and attends applicable study-related meetings; generates and distributes agendas, maintains and distributes meeting minutes, works with the PM to set up and maintain the Project Log, Risk Register, and study team contact lists; monitors/takes action on follow-up items from meetings; may facilitate routine update meetings including external site meetings in the absence of the PM, if needed; reviews documents for completeness and quality to reduce PM review time; participates in client visits as needed.
• Assists the PM with timeline updates (key milestones, resources, study information) upon request.
• Maintaining oversight of applicable eTMF QC tools/timing, and coordinating eTMF quality reviews when required.
• Routinely posts documents such as CRA reports, project deliverables, trackers, regulatory documents, metrics, agendas, and minutes to internal SharePoint site/client websites after completing administrator and program training on the required system.
• Serves as a sponsor and site contact in the absence of the PM, primarily during maintenance phases of varying complexity single and multi-site trials.
• Manages payment process per global finance standards.
• Sets up, coordinates, and maintains sponsor/internal training in accordance with applicable SOPs and processes.
• Assists with training and mentoring of new PCs.
• May oversee the development of protocol tools as required for the project (e.g., screening and enrolment log and development of investigator training).
• Assists the PM or mentor associate PCs/PCs in the setup of site regulatory binders (site master file including pharmacy file if required).
• May assist the Start Up Team with tasks including execution of confidentiality agreements, execution of site contracts and budgets, collection of regulatory documents and EC/IRB submissions, collating the information from the site into the appropriate tracking document.
• Leads external site calls.
• Acts as the primary point of contact for external sites during study maintenance, responding to queries, providing documents.
• Formats, posts, compiles, and enters budgeted hours into the project timeline.
• Independently maintains overall project trackers, including finance, screening, and vendors.
• May work with PM to create work scope changes as they relate to changes in the sponsor contract.
• May work with PM to liaise with vendor services, such as clinical laboratories, translation services, equipment suppliers and appropriate functions within Fortrea to support a project (e.g., QA, Client Services, Finance teams); maintains overall tracking documents.
• May provide data for monthly reporting, revenue recognition, and budgets; enters budgeted hours into the project timeline; consolidates revenue recognition timelines and provides output for monthly files in accordance with applicable processes.

Qualifications (Minimum Required):

• University/college degree, preferably in a healthcare/scientific field. Specific clinical research experience may be substituted for education.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• Knowledge of the clinical trial process with early clinical pharmacology experience preferred.
• Minimum 2-3 years of experience in a research environment.
• Minimum 1-2 years of experience working in a project management environment.
• Knowledge of protocol designs, study objectives, study procedures, and project-related timelines.
• Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines

Learn more about our EEO & Accommodations request here.

Originally posted on Himalayas