Clinical Research Coordinator, On-site, Omaha, NE

IQVIA•Omaha, NE

1d•Onsite

About The Position

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.

Requirements

Must demonstrate the ability to fulfill responsibilities of CRC Level I
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 challenges
Process improvement – support ideas and theories on process improvement for efficiency and effectiveness
Computer proficiency in use of Microsoft Word, Excel

Responsibilities

Coordinates advanced clinical research projects as the primary CRC on at least 4 studies of medium 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.).
Adheres to an IRB approved protocol
Obtains informed consent of research subjects
Supports the safety of research subjects, report adverse events.
Coordinates protocol related research procedures, study visits, and follow-up
Facilitates site qualification, study initiation, and monitoring visits, and study close-out activities
Ensures proper collection, processing, and shipping of laboratory specimens
May be asked to perform special project responsibilities and travel to other locations when needs arise
Complies with Avacare, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
Performs other duties as assigned