Associate Project Coordinator

We are seeking an Associate Project Coordinator to join our Phase I team. The successful candidate will be responsible for coordinating and completing project tasks in support of Project Management for low-complexity studies.

Responsibilities:

• Develop study-specific documents, such as Project Management Plans, Communication Plans, and Risk Mitigation Plans
• Create trial management tools to monitor study activity, including project setup activities, formats, posts, and compiles study timelines
• Attend, schedule, and organize study-related meetings; distribute agendas, maintain and distribute meeting minutes, Project and Risk Logs
• Work with the document specialist team to transfer documents to the Trial Master File (TMF) in accordance with applicable SOPs, policies, system, and client requirements
• Assist with project setup activities, such as study ID requests, SAS Environment Setup requests, and eTMF setup
• Maintain an internal standardized filing structure for study-related documents
• Assist with training compliance monitoring and updating the training matrix
• Participate in client visits as needed
• May assist with document transfer to the TMF, eTMF audit readiness efforts, and setup of eTMF QC tools
• May serve as a sponsor and site contact in the absence of the PM
• Assist with payments per global finance standards
• Assist in the setup, coordination, and maintenance of sponsor/internal training
• Assist in the development of project tools as required
• May assist with leading external site calls and acting as the primary point of contact for external sites

Qualifications:

• University/college degree, preferably in a healthcare/scientific field
• Minimum 1-2 years of experience in a research environment
• Knowledge of the clinical trial process, protocol designs, study objectives, study procedures, and project-related timelines
• Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines
• English language proficiency

Physical Requirements:

• Frequently stationary for 6-8 hours per day
• Repetitive hand movement of both hands
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Ability to access and use a variety of computer software
• 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

Salary: $20-27 USD per hour