Summary

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire Baylor team, sponsors, and monitors to ensure productivity and timely completion of studies.

Job Duties

Utilizing Good Clinical Practice, the CRC ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) 3) Include department/functional area specific tasks and responsibilities associated with this position/role.

• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
• Develops accurate source materials and ensures compliance from site staff
• Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and, Corticare and Baylor databases C08
• Ensures appropriate credentialing and training of the entire Baylor team
• Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol
• Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants

Specific Tasks for this current study:

• Screenings
• Enrolls patients in the study, explain processes and procedures to educate participants regarding the research study.
• Collects patient information; processes documents and enters information into a database
• Corresponds with patient throughout study
• Communicates professionally, effectively and timely with all relevant staff
• Maintains records and regulatory documents and records for research studies
• Discontinues when complete

Minimum Qualifications

• Education Required: High School diploma or GED.
• Experience Required: Two years of relevant experience.
• Certification/Licenses/Registration: None Required.