Associate Project Coordinator, CPS

Fortrea•Durham, NC

1d•Remote

About The Position

Fortrea’s Phase I team is seeking an Associate Project Coordinator to coordinate and complete project tasks in support of project management for low-complexity studies. The role initiates study-specific documents and develops trial management tools to monitor study activity, including project setup, formatting, posting, and compiling study timelines. The coordinator organizes study-related meetings and supports document transfer to the Trial Master File (TMF) in accordance with applicable procedures, policies, systems, and client requirements. Candidates must reside in the United States. The Associate Project Coordinator works with a Project Manager (PM) or more senior Project Coordinator (PC) on study documentation, training compliance, project setup, CTMS updates, study meetings, trackers, budgets, and site-related activities. Depending on study needs, the role may also support eTMF audit readiness, feasibility, study start-up, site regulatory binders, and external site communications. Work is performed with oversight where specified, and other duties may be assigned.

Requirements

University or college degree; a healthcare or scientific field is preferred. Specific clinical research experience may be substituted for education, and relevant 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 PC or PM to develop study-specific plans and documents for low-complexity studies, distribute drafts for review, compile comments, and route final documents.
Monitor study-team training compliance with a more senior PC or PM and update the training matrix as needed.
Maintain the standardized internal filing structure and proactively maintain study-related documents within it.
Complete project setup activities, such as requesting a study ID, requesting SAS environment setup, setting up eTMF, and creating study-specific distribution lists.
Assist the PM or a more senior PC with setting up and updating CTMS as required.
Attend and help organize study-related meetings; distribute agendas; maintain and distribute minutes, project logs, risk registers, and study-team contact lists; and participate in client visits as needed.
When required, assist document specialists with document transfer to the TMF in accordance with applicable SOPs, policies, systems, and client requirements.
Work with the PM and Document Specialist to support eTMF audit readiness, set up applicable eTMF QC tools, and coordinate eTMF quality reviews as needed.
After completing required administrator and program training, post study documents to internal SharePoint or client websites upon request.
Assist with business improvement initiatives, as directed and with oversight, to support quality, productivity, and continuous improvement.
Upon PM request and with the Associate Project Coordinator’s acceptance, serve as a sponsor and site contact during the PM’s absence, primarily during maintenance phases of routine, low-complexity single- and multi-site trials.
Assist the PM or a more senior PC with payments in accordance with global finance standards.
Assist with setting up, coordinating, and maintaining sponsor and internal training in accordance with applicable SOPs and processes.
Assist in developing project tools, such as screening and enrollment logs and investigator training materials.
Assist with setting up site regulatory binders, including a site master file and pharmacy file if required.
Assist with feasibility activities, including sending sites feasibility questionnaires and tracking responses.
Assist the Start Up team with tasks such as confidentiality agreements, contracts and budgets, regulatory-document collection, EC/IRB submissions, and tracking site information.
Assist the PM or a more senior PC 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.
Assist with formatting, posting, compiling, and entering budgeted hours into the project timeline.
Assist with maintaining project trackers, including finance, screening, and vendor trackers.
Work with the PM to assist with work-scope changes related to sponsor contract changes.
Perform other duties as needed or assigned.