What are the responsibilities and job description for the Clinical Research Coordinator position at Texas Health Research & Education Institute?
Texas Health Research and Education seeks to hire a Clinical Research Coordinator to work full-time (40 hours) in Clinical Research Trials.
Address : Klabzuba Tower : 1300 West Terrell Avenue, Fort Worth, TX 76104
Work Schedule
Day shift; full-time; 40 hours
Essential Functions
- Conduct clinical studies according to FDA regulations and ICH guidelines : from pre-study to startup to closeout. Including the design and maintenance organizational tools to conduct studies accurately and in compliance with GCP and ICH guidelines.
- Be knowledgeable of the Sponsor’s protocol so that all study activities are completed correctly and completely.
- Obtain proper written information consent from each study subject prior to participation in the study.
- Assign study subject numbers and maintain accurate and complete records of the receipt, administration, and return of all clinical supplies (including study drug).
- Assist in maintaining all required documentation in the study regulatory documentation file. Including processing and completing all IRB documentation. Including but not limited to : initial application, Informed Consent, modifications, amendments, Serious Adverse Events, advertisement, etc.
- Patient recruitment
- Conducting patient study visits.
- Schedule study subject’s visits.
- At each study subject’s visit perform defined activities of the study completely and accurately.
- Complete the source documents and CRFs / EDC for the study accurately, completely, and in a timely fashion.
- Be available, meet with and complete all monitoring queries, DCFs, deviations, etc.
- Communication of study / patient activities to manager / director, sponsor, monitors, patients, investigators, etc.