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Clinical Trials Associate, Medical Device - IQVIA MedTech

IQVIA Holdings Inc.

Morrisville, North Carolina

BASIC FUNCTIONS:

The primary role of the Clinical Trial Associate position is to administer, maintain, and coordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs) and Process Documents (PDs) and the Study Responsibilities Task List. Will act as a pivotal point of contact and support for the Project Management team. The Clinical Trial Associate may travel up to 30% to Project Management Team meetings or for other business-related reasons.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Oversee clinical supplies and distribution to sites. Communicate with sites on issues escalation related to clinical supplies.
  • Prepare, collect and provide support to sites on essential document collection and maintenance.
  • Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper).
  • Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File.
  • Prepare and submit central IRB submissions and communicate with the IRB. Provide support to sites for site and local IRB submissions.
  • Coordinate with Recruitment Management regarding advertising submissions to IRB.
  • Prepare Drug Release Authorization forms and collect required documentation.
  • Develop, data enter, and maintenance of study tracking databases/logs (i.e. Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
  • Coordinate tracking and uploading monitoring visit documents including Monitoring Visit Reports, confirmation/follow-up letters in TMF.
  • Prepare materials (e.g., binders, agendas, meeting minutes) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face Meetings (FTF).
  • Performs data entry into the CTMS system for study or client information.
  • May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • Perform administrative tasks to support team members with clinical trial execution as needed.

KNOWLEDGE, SKILLS AND ABILITIES:

  • General knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority.
  • Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
  • Strong written and verbal communication skills.
  • Effective time management and organizational skills.
  • Attention to detail and accuracy in work
  • Aptitude for handling and proofreading data.
  • Strong customer service orientation.
  • Ability to travel (e.g. Investigators Meetings)

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effort required to perform normal job duties (unless otherwise indicated)

MINIMUM RECRUITMENT STANDARDS:

  • College degree in any of the life sciences preferred, or with a certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

Or

  • ≥ 2 years’ experience with IQVIA Biotech Clinical or working within the health sciences field in a similar position.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act.

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

Job posted: 1970-01-01

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