FSP Clinical Trial Coordinator
About The Position
The Clinical Trial Coordinator provides administrative and technical support to the Project Team. The role supports audit readiness by ensuring files are reviewed according to organizational SOPs and department guidance. It also provides administrative support for site activation and helps develop the site activation critical path to promote rapid site activations. The coordinator may use local knowledge, organizational systems, external site lists, and sponsor directives to develop and review site lists for feasibility activities and provide local input to site tiering. The role may also include buddying and training new staff during onboarding. The coordinator ensures trial materials and documentation are available for setup and execution, manages trial and investigator site files, clinical systems, supplier coordination, site documentation, and operational tracking.
Requirements
- High School Diploma or equivalent (such as GED), a relevant formal academic or vocational qualification, and at least one year of relevant experience; or a bachelor's degree in a related field with 0 or more years of experience.
- Highly developed administrative skills, with 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, with culturally sensitive, clear, and transparent communication.
- Strong MS Office skills, including Excel, Word, PowerPoint, and Outlook.
- Knowledge of 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 the Trial Master File (TMF) and Investigator Site File (ISF), including setup, ongoing filing, and completeness before archiving.
- Manage clinical systems, ensuring 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 schedule in organizational SOPs and department guidance.
- Provide administrative support for site activation activities and help develop the site activation critical path.
- Develop and review site lists for feasibility activities and provide local input into site tiering, as needed.
- Act as an onboarding buddy and provide training to new staff, as needed.
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What This Job Offers
Job Type
Full-time
Education Level
High school or GED
