Associate Project Coordinator

This is a fully remote position, open to applicants in United States.

📋 Description

• Coordinate and execute project tasks that support Project Management for studies of low complexity.

• Initiate documents specific to the study, such as Project Management Plans, Communication Plans, and Risk Mitigation Plans.

• Create tools for trial management and oversee study activities, project setup, timelines, and trackers.

• Schedule and arrange meetings associated with the study; distribute agendas, and maintain and circulate minutes, project logs, risk registers, and contact lists.

• Ensure the transfer of study documents to the Trial Master File in compliance with SOPs, policies, systems, and client specifications.

• Collaborate with senior Project Coordinators or Project Managers to develop, distribute, and finalize study-specific plans and training matrices.

• Keep standardized filing systems and proactively manage study-related documents.

• Complete project setup tasks, including requests for study IDs, SAS environment configuration, eTMF, and distribution lists.

• Aid in the setup and updates of the CTMS.

• Engage in client visits and assist in eTMF audit readiness and quality evaluations.

• Upload post-study documents to internal SharePoint or client websites following necessary training.

• Support initiatives aimed at business improvement.

• Act as the sponsor and site contact during maintenance phases when requested and authorized.

• Assist with payments, sponsor/internal training, project tools, regulatory binders, feasibility assessments, site startup, contracts, budgets, regulatory documents, and EC/IRB submissions.

• Lead or assist with calls to external sites, serving as a point of contact for those sites.

• Maintain project timelines, finance/screening/vendor trackers, and facilitate work-scope changes related to sponsor contracts.

• Carry out other assigned responsibilities.

⛳️ Requirements

• All applicants must reside in the United States.

• A university or college degree in a healthcare/scientific field is preferred; relevant clinical research experience may substitute for educational qualifications.

• Equivalent relevant experience may be accepted in place of educational credentials.

• Proficiency in English is required for speaking, writing, and reading.

• Familiarity with the clinical trial process is necessary; experience in early clinical pharmacology is preferred.

• A minimum of 1–2 years of experience in a research setting is required.

• Understanding of protocol designs, study objectives, study procedures, and project-related timelines is essential.

• Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines is necessary.

• Regular and consistent attendance is expected.

• Ability to use a range of computer software, both proprietary and commercially available.

• Capability to fulfill the physical requirements of the role, including stationary work, repetitive hand movements, bending/twisting, and lifting 15–20 lbs.

• Flexibility in working hours may be necessary.

🏝️ Benefits

• Comprehensive health insurance coverage.

• Opportunities for professional development and training.

• Flexible working hours and remote work options.

• Supportive team environment and culture.