Associate Project Coordinator, CPS

Fortrea•Durham, CA

20h•$20 - $27•Remote

About The Position

The Associate Project Coordinator supports Project Management in coordinating and completing tasks for low-complexity clinical studies. Working with a more senior Project Coordinator or Project Manager, the role helps prepare study-specific plans and tools, monitor study activity and timelines, coordinate meetings, maintain project records and trackers, and support project setup. The position also supports document management and transfer to the Trial Master File (TMF), including eTMF audit readiness and quality review activities, in accordance with applicable SOPs, policies, systems, and client requirements. The role may also assist with training coordination, payments, feasibility, site start-up and regulatory activities, sponsor and site communications, project budget-hour tracking, and work-scope changes. It may serve as a sponsor and site contact during certain maintenance phases when requested by the Project Manager and accepted by the Associate Project Coordinator. All candidates must reside in the United States.

Requirements

University or college degree, preferably in a healthcare or scientific field; specific clinical research experience may substitute for education.
Relevant and equivalent experience may be considered in lieu of educational requirements.
English speaking, writing, and reading proficiency.
Minimum 1–2 years of experience in a research environment.
Knowledge of the clinical trial process.
Knowledge of protocol designs, study objectives, study procedures, and project-related timelines.
Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines.
Ability to access and use a variety of in-house and off-the-shelf computer software.
Regular and consistent attendance.

Nice To Haves

Early clinical pharmacology experience.

Responsibilities

Work with a more senior Project Coordinator or Project Manager to develop study-specific plans and documents for low-complexity studies, distribute them for review, compile comments, and route final versions.
Monitor study-team training compliance and update the training matrix as needed.
Maintain and proactively organize study-related documents in the internal standardized filing structure.
Complete project setup activities, such as requesting a study ID and SAS environment, setting up eTMF, and creating study-specific distribution lists.
Assist with setting up and updating the CTMS as required.
Attend and help organize study meetings; distribute agendas; maintain and distribute minutes, project and risk logs or registers, and study-team contact lists; and participate in client visits as needed.
Assist with transferring documents to the TMF, support eTMF audit readiness, help set up eTMF quality-control tools, and assist with coordinating eTMF quality reviews.
Post specified documents to internal SharePoint or client websites after completing required system training.
Assist with business improvement initiatives under direction and oversight.
When requested by the Project Manager and accepted by the Associate Project Coordinator, serve as a sponsor and site contact in the Project Manager's absence, primarily during maintenance phases of routine, low-complexity single- and multi-site trials.
Assist with payments in accordance with global finance standards.
Assist with setting up, coordinating, and maintaining sponsor and internal training.
Help develop project tools, such as screening and enrollment logs, and support investigator training development.
Assist with setting up site regulatory binders, including pharmacy files if required.
Support feasibility activities, including sending questionnaires to sites and tracking responses.
Assist the Start Up team with confidentiality agreements, contracts and budgets, regulatory document collection, EC/IRB submissions, and tracking site information.
Assist with leading external site calls and, when assigned, act as the primary contact for external sites during study maintenance by responding to queries and providing documents.
Format, post, compile, and enter budgeted hours into project timelines.
Help maintain overall project trackers, including finance, screening, and vendor trackers.
Assist the Project Manager with work-scope changes related to sponsor contract changes.
Perform other duties as needed or assigned.