• Job Description

  Req#: R1381793

  Job Overview
  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.

  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.

  Qualifications
  • Bachelor's Degree Required
  • 3 years administrative support experience.
  • Equivalent combination of education, training and experience.
  • 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.

  IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

  We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

  IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

  The potential base pay range for this role, when annualized, is $32,200.00 - $89,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

• About the company

  IMS Health and Quintiles are now IQVIA. We are committed to providing solutions that enable healthcare companies to innovate with confidence, maximize opportunities and, ultimately, drive healthcare forward. We do this via breakthroughs in insights, t...

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