Description
We are seeking a Clinical Files Specialist to join our team in a hybrid work arrangement. As a Clinical Files Specialist, you will perform daily administrative activities to ensure a complete and accurate Trial Master File delivery.
Essential Functions
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems.
- Assist the clinical team with regulatory documentation, preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
- Assist with periodic review of study files for completeness, preparation, handling and distribution of Clinical Trial Supplies, and maintenance of tracking information.
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Qualifications
- Bachelor Degree in Life Science or Healthcare.
- 1-2 years administrative support experience or an Intern experience in clinical research or pharma.
- Availability to go to the office: Hybrid position.
- Written and verbal communication skills including good command of English language.
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.