Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, 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 (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
- Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of study files and completeness.
- Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Coordinate the tracking and management of 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.
- Act as a mentor for less experienced Clinical Trial Assistants (CTAs).
- Assist with training and onboarding of new CTAs.
- May serve as subject matter expert for business processes.
- May lead CTA study teams.
- May assist with interviewing and screening of potential new team members
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
- May participate in departmental quality or process improvement initiatives.
- High School Diploma or equivalent Req
- 5 administrative support experience.
- Equivalent combination of education, training and experience.
- Minimum two years clinical research experience strongly preferred.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Effective 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.
- Knowledge 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.
