What are the responsibilities and job description for the CLINICAL RESEARCH COORDINATOR II position at Bauer's Intelligent Transportation, Inc.?
Clinical Research Coordinator II
Job Details
Job Location
Presbyterian Hospital of Dallas / DCPM - Dallas, TX
Position Type
Full Time
Job Shift
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 :
Knowledge, Skills & Abilities :
