Senior Project Coordinator - Early Phase

Covance is looking to recruit a Senior Project Coordinator. This role sites within the clinical pharmacology group in Leeds and can be part home based and part office based. It is very much a junior project management level role focused on early phase studies.

Ideally we would welcome someone from the NHS or someone who has some exposure to Phase I studies and is looking to get into commercial clinical operations in a project coordination role.

Please call Marc Joseph at Covance on 01753 216664 for further information.

JOB DETAILS:-

Independently owns, creates and maintains study specific documents (e.g. Project Management Plan, Communication Plan, Risk Register, Project Specific Training Matrix and any other applicable plans as required), including compliance with client-specific requirements, for studies of varying complexity including external site studies. Distributes them to the study team and/or sponsor for review, compiles comments, and routes final documents. Independently 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. 

Independently uses and develops trial management tools to monitor study activity and perform tasks, including project setup activities (e.g. study ID request, SAS Environment Setup request, Study-specific Distribution Lists, etc.)

Manages the setup and updating of CTMS; maintains knowledge and 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, independently sets up and maintains the Project Log, Risk Register, and study team contact lists; monitors/takes action on follow-up items from meetings; will facilitate client meetings including external site meetings in the absence of the PM; reviews documents for completeness and quality to reduce PM review time; participates in client visits as needed.

Independently generates presentations and correspondence.

Makes timeline updates (key milestones, resources, study information) as required for the project.

If required may assist document specialists in document transfer to the Trial Master File (TMF) in accordance with applicable SOPs, policies, system, and client requirements; independently leads eTMF audit readiness efforts by working with the PM and Document Specialists (DS), maintaining oversight of applicable eTMF QC tools/timing and coordinating eTMF quality reviews when required. Mentors more junior members of the team in eTMF audit readiness.

Proactively posts documents such as CRA reports, project deliverables, trackers, regulatory documents, metrics, agendas, and minutes to client websites after completing administrator and program training on the client system.

Develops, implements, and participates in business improvements initiatives to drive quality, productivity, and continuous improvements across different business units; offers ideas and suggestions to the PM or management on operational and logistical challenges and resolutions.

Serves as direct sponsor and site contact in the absence of the PM, even during critical phases of varying complexity single and multi-site trials, may have limited authority to act in lieu of the PM, if needed.

Manages payment process per global finance standards.

Oversees training and mentoring of other PCs; independently trains/mentors any department staff, including PMs, on tasks/processes/areas in areas of expertise; responsible for routine development/review/revision of PC training materials; maintains subject matter expertise in all aspects of the TMF.

Coordinates and manages support across large global studies. Drives efficiency and quality in coordination activities and applicability to clinical trial management.

Provides support with reviewing and managing all aspects of assigned projects (financials, enrolment, vendors etc.).

Assists the PM or mentors an associate PC or PC in the setup of site regulatory binders (site master file including pharmacy file if required).

Independently oversees feasibility site start up activities including feasibility, providing sites with feasibility questionnaires and protocol as required, collating the information from the site into the appropriate tracking document

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.  

Independently maintains overall project trackers, including financial, screening, and vendors.

Formats, posts, compiles, and enters budgeted hours into the project timelines

Independently creates work scope changes as they relate to changes in the sponsor contract.

Independently liaises with vendor services, such as clinical laboratories, translation services, equipment suppliers and .appropriate functions within Covance to support a project e.g. QA, Client Services, Finance teams.

Provides support with project planning and forecasting (including plans and Gantts).

May maintain revenue recognition and metric information for stand-alone/single-service Biometrics projects, with oversight from a PM.

May independently provide data for monthly reporting, revenue recognition, and budgets; consolidate revenue recognition timelines and provide output for monthly files in accordance with applicable processes. May assist PM in maintaining project dashboards.

May perform supervisory duties including, but not limited to, interviewing, hiring, training, developing, performance evaluation, intervention, discipline, and discharge for Project Coordinators

Performs other duties, as assigned.

Please call Marc Joseph at Covance on 01753 216664 for further information.