Job Location: St Leonards Sydney NSW

JOB OVERVIEW

Job Profile Summary

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.

Responsibilities

Essential Functions

• 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.

• Assist the clinical team with 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 for completeness.

• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.

• Assist with 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.

• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience

• Typically requires a minimum of 2 years of experience.

• Requires basic job knowledge of systems and procedures obtained through prior work experience or education.

• High School Diploma or equivalent

• Additional Work Experience

• Preferred 3 years administrative support experience.

• Equivalent combination of education, training and experience.

Skills and Abilities

• Computer skills including working knowledge of

• Microsoft Word, Excel and PowerPoint.

• 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.

• Awareness 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.

Why IQVIA

We've changed, can you? Our Industry is like no other, with continued advances in Healthcare we evolve as we grow. Maintaining our role as a Global Leader requires unique employees. This isn't your every day job. At the heart of what we do true passion for better patient outcomes drives us. As a subject matter expert you know what the role of a CRA involves, and we'll offer you the opportunity to develop your career. In 2018, 41% of our jobs were successfully filled by our internal talent.

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 .

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