Clinical Research Coordinator (CRC) comprises an integral part of the research team. Working under the PI, he/she/they is/are responsible for conducting each study in accordance with all applicable regulations and guidelines. Some responsibilities of the Clinical Research Coordinator (CRC) depending on need include:
Facilitate and coordinate the daily cancer clinical trial activities
Conduct clinical trials per Good Clinical Practice and CFR guidelines
Work directly with on-site research staff of Investigators, Nurses, Medical Assistants.
Accurate and timely trial data collection and reporting
Submit regulatory documents to IRB and Sponsor
Attend investigator meeting(s)
Obtain physician signatures
Screen, track and schedule trial patients
Teach subjects/patients about protocol expectations for trial visits
Perform study/protocol procedures in a detailed, accurate manner
Maintain study files on site
Report all adverse events and SAEs
Collect laboratory specimens, processing and shipping lab work
Maintain communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel.
Complete case report forms (CRF) and electronic data capture (EDC) for PI review and approval
Coordinate site study monitor and sponsor visits
Maintain study-specific supplies
Prepare for study closure and archiving
Knowledge of medical terminology (Oncology and Urology preferred).
Knowledge of good clinical practice, FDA, OHRP, HIPAA policies.
Proficiency with the Microsoft Office Suite, Google Docs, Sharepoint.
Meticulous attention to details
3 years of equivalent experience in medical clinic, research coordination required
CCRP, ACRP certification preferred but not required
Prior experience with Urology and Oncology clinical trials strongly preferred
Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed.
Some EMR (electronic medical records) experience required
Some Electronic Data Capture (Rave, Oracle, Inform, etc.) experience required
Additional Salary Information: Negotiable based on qualifications and experience
About Urology Clinics of North Texas Office of Clinical Trials
Urology Clinics of North Texas (UCNT) is the premier name in urologic treatment in the Dallas-Fort Worth metro area. Initially formed in 1999, Urology Clinics of North Texas delivers state-of-the-art care to patients at 18 locations throughout the North Texas area. Clinical research studies are conducted through our centralized Clinical Trials Office, located in Dallas Texas.