Senior Clinical Trial Assistant Role Summary:
This role is responsible for performing 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.
The successful candidate will assist clinical research associates (CRAs) and regulatory and start-up (RSU) team with accurately updating and maintaining clinical documents and systems, track site compliance and performance within project timelines, collaborate on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Key Responsibilities
* Assist CRAs and RSU team with accurately updating and maintaining clinical documents and systems.
* Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
* 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.
Requirements
* Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
* Minimum 6 months 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.
About IQVIA
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.