Principal Clinical Trial Coordinator – FSP

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Participates in kick-off meetings and provides training support for team members, investigators, or clients as necessary.

• Acts as the eTMF lead for studies, managing client integration and (e)TMF activities.

• Delivers technical and administrative support for project coordination to achieve study-level milestone objectives.

• Aids in the preparation and evaluation of EDP/RCR packages.

• Assists in the creation of country or site-specific documentation.

• Supports study closure activities, including the final TMF review and completion of the TMF certification form (DEV-FORM-1939).

• Aids in preparations for Investigator Meetings.

• Oversees and coordinates the logistical components of clinical projects.

• Initiates the development of all project/program plans required by client contracts.

• Coordinates training needs specific to projects/programs/protocols and therapeutic areas.

• Monitors and follows up on all training, non-disclosure agreements, and security clearance requests.

• Executes basic project financial management tasks as assigned.

• Serves as the task order/work assignment lead for smaller scopes of work on contracts/projects with low complexity.

• Raises compliance issues related to established project-specific parameters and client expectations.

• As Project Specialists, ensures that the contracted services and expectations of assigned projects are fulfilled.

• Maintains timely and effective communication among team members and site staff.

• Provides support for quality assurance activities, including preparation for audits and internal reviews.

• Engages in discussions with colleagues to foster collaboration and best practices.

• Enhances therapeutic knowledge and expertise.

⛳️ Requirements

• A bachelor's degree is preferred.

• Prior experience that imparts the knowledge, skills, and abilities necessary to perform the job (equivalent to 5+ years).

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Remote work options.