Project Coordinator Cps

hace 2 semanas

Ciudad de México Fortrea A tiempo completo

The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations [e.g., Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP)] in the performance of their role.

Job Summary:

- 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.
- 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 mínimal 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.
- Generates presentations and correspondence with PM review.
- Assists the PM with timeline updates (key milestones, resources, study information) upon request.
- 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.
- 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.
- Independently participates in business improvements initiatives as assigned to drive quality, productivity, and continuous improvements across different business units; develops new ideas for improvement initiatives within own business unit.
- 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).
- Assist the PM or more senior PC as required with feasibility including providing sites with feasibility questionnaire and tracking responses.
- May assist the Start Up Team with tasks including execution of confidentiality agreements, execution of site contract

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