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Clinical Research Coordinator

Job Details

Job Location

8230 Walnut Hill Lane Ste. 700, Dallas, TX 75231 - Dallas, TX

Description

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

Qualifications

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.