FSP Clinical Trial Coordinator

Thermo Fisher Scientific • Wilmington, NC

1d

About The Position

The Clinical Trial Coordinator provides administrative and technical support to the Project Team and supports audit readiness by ensuring files are reviewed according to the schedule in the organization’s SOP and department guidance. The role also provides administrative support for site activation activities and helps develop the critical path for site activation to support rapid activations. The coordinator may contribute local knowledge and other resources to develop and review site lists for feasibility activities and provide local input into site tiering. The role may also include serving as an onboarding buddy and training new staff as needed.

The coordinator ensures timely availability of trial materials and documentation for clinical-trial setup and execution; manages Trial Master Files (TMF) and Investigator Site Files (ISF); maintains clinical systems and operational tracking tools; coordinates site supplies, logistics, and import/export compliance with suppliers; supports site documentation and activities; and assists with site initiation readiness and site progression.

Requirements

• High school diploma or equivalent (e.g., GED) and a relevant formal academic/vocational qualification, with at least one year of relevant experience; or a bachelor’s degree in a related field with 0+ years of experience.
• Highly developed administrative skills and excellent document-management and organizational skills.
• Ability to manage multiple assignments and work independently.
• Good understanding of project-related priorities.
• Strong verbal and written communication skills, including culturally sensitive, clear, and transparent communication.
• Strong MS Office skills, including Excel, Word, PowerPoint, and Outlook.
• Knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP), Good Documentation Practice, and local regulatory regulations.

Responsibilities

• Ensure timely availability of trial materials and related documentation for clinical-trial setup and execution.
• Manage TMF and ISF setup, ongoing filing, completeness, and preparation prior to archiving.
• Manage clinical systems, including accurate reporting, data completeness, and access management.
• Coordinate with suppliers to ensure site supplies, logistics, and import/export compliance.
• Support site activities, including confidentiality agreements, feasibility questionnaires, and system forms.
• Assist with site initiation readiness.
• Maintain tracking tools for operational oversight.
• Coordinate site documentation to support timely site qualification and progression.
• Support audit readiness by ensuring files are reviewed according to the organization’s SOP and department guidance.
• Provide administrative support for site activation and help develop the critical path for site activation.
• Develop and review site lists for feasibility activities and provide local input to the site tiering process, as needed.
• Act as an onboarding buddy and provide training to new staff, as needed.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED