Overview
Clinical Trial Assistant/sponsor dedicated Jobs in Centurion, South Africa at IQVIA
Position: Â Clinical Trial Assistant (sponsor dedicated
Job Overview
Perform daily administrative activities, in conjunction with theClinical ResearchAssociates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Essential Functions
AssistClinical ResearchAssociates (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 withtraining and onboardingof 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 orprocess improvementinitiatives.
Qualifications
High School Diploma or equivalent Req.
5 years administrative support experience.
Equivalent combination ofeducation, training and experience.
Minimum two yearsclinical researchexperience strongly preferred.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
Effective written and verbalcommunication skillsincluding 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 applicableclinical researchregulatory 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.
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Title: Clinical Trial Assistant/sponsor dedicated
Company: IQVIA
Location: Centurion, South Africa
Category: Healthcare, Research/Development
