Clinical Trial Study Coordinator

Title: Clinical Trial Study Coordinator

Location: Remote, ideally EST or CST

Duration: 12-month contract, with likelihoods of extension

Start Date: ASAP

Job Description:

The Project Study Coordinator will assist in overseeing project activities, building out capabilities, and developing operational plans. This role will involve collaborating with project teams, ensuring effective coordination, and supporting the successful execution of project goals. This resource will assist with study management operations and decentralized strategies and tactics in clinical trials. The study coordinator must be highly organized, an effective communicator, and understand study protocol workflows.

Responsibilities:

Project Oversight

• Assist in the coordination and monitoring of ongoing clinical projects and studies to ensure they are progressing as planned.
• Help identify potential risks or delays and collaborate with the team to mitigate them.

Operational Planning:

• Support the development and refinement of operational plans, timelines, and resource allocations, ensuring alignment with study milestones and company goals.

Capability Building:

• Contribute to the identification and development of new capabilities, systems, and processes aimed at improving project execution and operational efficiency.

Stakeholder Coordination:

• Serve as a liaison between internal teams, external vendors, and study sites to facilitate communication and ensure that all stakeholders are informed of key project developments.

Documentation and Reporting:

• Assist in preparing project-related documentation, including reports, presentations, and other materials, ensuring compliance with regulatory standards and company protocols.

Tracking and Monitoring:

• Support the tracking of study progress against key milestones, including budget, timelines, and resource utilization.

Administrative Support:

• Provide general administrative support for the project management team, including scheduling meetings, organizing project documentation, and preparing materials for meetings with key stakeholders.

Qualifications:

• Bachelor’s degree in life sciences, healthcare, public health, business, or a related field; equivalent experience in clinical research or project coordination may be considered.
• 2+ years of experience in clinical research, study coordination, project management, or clinical trial operations – CRO vendor management exp would be nice
• Working knowledge of clinical trial lifecycle, study protocol workflows, and GCP requirements; familiarity with decentralized clinical trial (DCT) models is strongly preferred.
• Demonstrated ability to support study management activities, including operational planning, milestone tracking, and cross-functional coordination.
• Strong organizational skills with the ability to manage multiple projects, timelines, and priorities in a fast-paced environment.
• Excellent written and verbal communication skills, with experience collaborating across internal teams, external vendors, and clinical study sites.
• Experience preparing and maintaining study documentation, reports, and presentations in compliance with regulatory and company standards.
• Proficiency with project management tools, clinical trial systems (e.g., CTMS, Veeva), and Microsoft Office (Excel, PowerPoint, Word).
• Ability to identify risks, escalate issues appropriately, and support mitigation strategies.
• High attention to detail, strong problem-solving skills, and a proactive, team-oriented mindset