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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.
- Responsible for the coordination and completion of project tasks in suppot of Project Management for low complex 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.
- Works with a more senior PC or PM in 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 complex studies; distributes them to the study team and/or sponsor for review, compiles comments, and routes final documents.
- Works with a more senior PC or PM to monitor training compliance of the study team and update the training matrix as required.
- Maintains an internal standardized filing structure for study-related documents; proactively maintains documents within the filing structure.
- Responsible for project setup activities (e.g., study ID request, SAS Environment Setup request, eTMF, Study-specific Distribution Lists, etc.).
- Assists the PM or a more senior PC in the setup of and updating of CTMS, as required.
- Attends and assists in the organization of study-related meetings, as required; distributes meeting agendas; maintains and distributes meeting minutes, Project Log, Risk Register, and study team contact lists; participates in client visits as needed.
- 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; works with the PM and Document Specialist (DS) to lead eTMF audit readiness efforts and to set up any applicable eTMF QC tools, and may assist in the coordination of eTMF quality reviews.
- Upon request, posts documents such as CRA reports, project deliverables, trackers, regulatory documents, metrics, agendas, and minutes to internal SharePoint/client websites after completing administrator and program training on the required system.
- As directed and with oversight, assists with business improvements initiatives to drive quality, productivity, and continuous improvements across different business units.
- Upon PM request and with Associate Project Coordinator (PC) acceptance, may serve as a sponsor and site contact in the absence of the PM, primarily during maintenance phases of routine single and multi-site low-complexity trials.
- Assists the PM or a more senior PC with payments per global finance standards.
- Assists in the set-up, coordination and maintenance of sponsor/internal training in accordance with applicable SOPs and processes.
- Assists in the development of project tools as required for the project (e.g., screening and enrolment log and development of investigator training).
- May assist the PM or a more senior PC in the set up site regulatory binders (site master file including phannacy file if required).
- Assists the PM, or more senior PC as required with feasibility, including providing sites with feasibility questionnaire and tracking responses.
- May assist the Stat1Up team with tasks including execution of confidentiality agreements, execution of contracts and budgets, collection of regulatory documents and EC I IRB submissions, collating the information from the site into appropriate tracking document.
- May assist the PM or more senior PC with leading external site calls.
- May act as the primary point of contact for external sites during study maintenance, responding to queries, providing documents.
- Assists the PM or a more senior PC in the formatting, posting, compiling and entering budgeted hours into the project timeline.
- Assists the PM/more senior PC in maintaining overall project trackers, including financial, screening, and vendors.
- May work with the PM to assist with work scope changes as they relate to changes in the sponsor contract.
- Performs other duties, as assigned.
**Education**:
- University/college degree, preferably in a healthcare/scientific field. Specific clinical research
