Job Information
Bauer's Intelligent Transportation, Inc. Clinical Research Coordinator II in Dallas, Texas
Clinical Research Coordinator II
Job Details
Job Location
Presbyterian Hospital of Dallas/DCPM - Dallas, TX
Position Type
Full Time
Job Shift
Day
Job Category
Health Care
Description
Clinical Research Coordinator (CRC) II comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal and hospital regulations. Some responsibilities of the Clinical Research Coordinator (CRC) II depending on need include:
Facilitate and coordinate the daily cancer clinical trial activities
Coordinate 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 and staff signatures
Recruit subjects/patients
Screen, track and schedule trial pts
Coordinate the Informed Consent Process, ensuring all patients are properly consented prior to initiating clinical trial procedures
Teach subjects/patients about protocol expectations for trial visits
Perform study/protocol procedures in a detailed, accurate manner
Maintain study files completely and accurately
Report all adverse events and SAEs within required timelines
Collect laboratory specimens, process/ship 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
Respond to all data queries and sponsor requests in a timely manner
Coordinate site study monitor and sponsor visits
Maintain study-specific supplies
Prepare for study closure and archiving
Maintain appropriate training required to carry out protocol-driven activities as delegated by the PI
Other duties within the scope of a Clinical Research Coordinator
Qualifications
Job Qualifications:
3-5 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 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
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 always adhere to site confidentiality guidelines.
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.