Responsibilities

Clinical Research Coordinator I (CRC I) is a fundamental member of the research team. Working under the PI, he/she is responsible for coordinating the conduct of clinical trials in accordance with all applicable regulations and guidelines. Depending on experience, the CRC I will operate under close supervision and guidance while in training. Some responsibilities of the CRC I, depending on need include:

Facilitate and coordinate the daily cancer clinical trial activities
Coordinate the conduct of clinical trials per Good Clinical Practice and CFR guidelines
Work cooperatively 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
Recruit subjects/patients
Screen, track and schedule trial pts
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

Job Qualifications

At least 1 year of experience in a clinical research setting, often transitioning from an assistant role
Prior experience in an oncology or urology setting 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 preferred

Knowledge, Skills & Abilities

Excellent organization and communications skills required.
Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
Must be detail oriented and have the ability to follow-through.
Ability to effectively manage time and prioritize workload.
Must practice discretion and adhere to site confidentiality guidelines at all times.
Must have computer skills including the use of Microsoft Office.

Urology Clinics of North Texas, PLLC

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Clinical Research Coordinator