Sr Clinical Trials Assistant (FSP)

Are you looking for a career change? A step up in your career as a CTA? IQVIA may have the role for you!

Our Clinical FSP team is looking for a Senior Clinical Trials Assistant to join one of our top Pharmaceutical clients in Sydney/Melbourne.

This role is office based (working from home during Covid-19 restrictions)

0.8 FTE (4 days a week) or full time available

Key Responsibilities:

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 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

Skills and Experience Required:

Minimum of two years Clinical Trials Assistant experience within a CRO or Pharmaceutical

Three- four years administrative support in clinical research desired

High School Diploma and/or Bachelors degree in a relevant field

Must have experience updating and maintaining clinical documents via TMF/ETMF and other related systems

Knowledge of applicable clinical research regulatory requirements. i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Knowledge of applicable protocol requirements

Strong computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint

Strong written and verbal communication skills including good command of English Language

Effective time management and organizational skills

Must have permanent working rights in Australia (Australian Citizen/Permanent Resident)

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.