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.
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
3 years of administrative support experience or 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.