On Site - Clinical Research Coordinator

IQVIA Holdings Inc.

Omaha, Nebraska, United States

Job Overview

This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. The employee, working closely with study team members, will achieve study objectives and corporate goals. 

Essential Functions

  • Coordinates advanced clinical research projects as the primary CRC on at least 1-4 studies of low to high complexity, as well as back-up CRC on other studies when needed

  • Assures that the integrity and quality of clinical research trials is maintained

  • Develops and implements patient recruitment strategies; actively recruits to ensure enrollment targets are achieved

  • Oversees the work of research assistants and trains junior staff as appropriate

  • Works effectively with multidisciplinary, ancillary, and inter-professional research teams

  • Functions independently, and is able to identify situations where additional support is necessary

  • Completes all protocol related training 

  • Performs patient/research participant scheduling 

  • Collects patient/research participant medical history 

  • Collects and maintains source documentation

  • Manages inventory and administers test articles/investigational product to participants

  • Performs data entry and query resolution 

  • Supports the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging, and laboratory handling manuals, etc.). 

  • Supports the safety of research subjects, report adverse events 

  • Coordinates protocol related research procedures, study visits, and follow-up 

  • Facilitates pre-study, site qualification, study initiation, monitoring visits, and study close out activities 

  • Collects, processes and ships laboratory specimens 

  • May be asked to perform special project responsibilities and travel to other locations when needs arise

  • Complies with IQVIA, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines

  • Performs other duties as assigned

Qualifications

  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines

  • Knowledge and experience of site operations and the drug development process

  • Excellent written and verbal communication skills – must be comfortable and effective in communicating with potential study participants from a diverse population

  • Interpersonal skills - open to others’ ideas and willing to learn new things; respond well to questions and challenge

  • Process improvement – support ideas and theories on process improvement for efficiency and effectiveness

  • Computer proficiency in use of Microsoft Word, Excel

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.  https://

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

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.

Job posted: 2023-10-04

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