Our Phase I team is currently seeking Associate Project Coordinator to join their growing group! All candidates must reside in the United States.
Job Overview:
- Responsible for the coordination and completion of project tasks in support 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.
Summary of Responsibilities:
- 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 pharmacy 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 Start Up team with tasks including execution of confidentiality agreements, execution of contracts and budgets, collection of regulatory documents and EC / 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 finance, screening, and vendors.
- May work with the PM to assist with work scope changes as they relate to changes in the sponsor contract.
- All other duties as needed or assigned.
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.
- Speaking/Writing/Reading: English required.
Experience (Minimum Required):
- Knowledge of the clinical trial process with early clinical pharmacology experience preferred.
- Minimum 1-2 years of experience in a research environment.
- Knowledge of protocol designs, study objectives, study procedures, and project-related timelines.
- Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines.
Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
- Target Pay Range: $20-27 USD per hour
- #LI - Remote Applications will be accepted on an ongoing basis.
Learn more about our EEO & Accommodations request here.
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