This is position is on-site at our Fremont, Nebraska location
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. 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