Description
Perform daily administrative activities to ensure a complete and accurate Trial Master File delivery in conjunction with Clinical Research Associates and Regulatory and Start-Up teams.
Essential Functions
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with updating and maintaining clinical documents and systems, such as Trial Master File (TMF), to track site compliance and performance within project timelines.
- Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures.
- Conduct periodic reviews of study files for completeness.
- Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Qualifications
- High School Diploma or equivalent
- 3 years of administrative support experience
- Equivalent combination of education, training, and experience
- Computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint
- Written and verbal communication skills, including good command of English language
- 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, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of applicable protocol requirements