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.
- Collaborate with the clinical team on preparing, handling, distributing, filing, and archiving clinical documentation and reports.
- Assist with periodic review of study files and completeness.
- Collaborate with CRAs and RSU on preparing, handling, and distributing Clinical Trial Supplies and maintaining 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.
- Mentor less experienced Clinical Trial Assistants (CTAs).
- Assist with training and onboarding new CTAs.
- May serve as a subject matter expert for business processes.
- May lead CTA study teams.
- May assist with interviewing and screening potential new team members.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completing required training.
- May participate in departmental quality or process improvement initiatives.
Qualifications
- High School Diploma or equivalent.
- 5 years of administrative support experience.
- Equivalent combination of education, training, and experience.
- Minimum two years of clinical research experience strongly preferred.
- Computer skills including proficiency in Microsoft Word, Excel, and PowerPoint.
- Effective written and verbal communication skills, including good command of English.
- Effective time management and organisational 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 Harmonisation (ICH) guidelines as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.