Clinical Research Coordinator

Company

SpineMark CRO @ Texas Back Institute


Company Type

Contract Research Organization


Job Description

SUMMARY: The Clinical Research Coordinator (CRC) is responsible for the conduct, coordination and related tasks identified through the clinical research operations of Spinemark Clinical Research Organization (CRO) at Texas Back Institute (TBI) and its research projects. The CRC will work with the Director of Research to maintain data integrity, conduct research related study visits and be responsible for its implementation and ongoing coordination. The CRC is responsible for assisting the Director of Research and Regulatory/Compliance Officer in maintaining compliance and adherence to all regulating agencies concerning clinical research.

?Responsible for all duties related to execution of IDE and/or other IND studies
?Performing all work in compliance with FDA, IRB, GCP and ICH regulations and
?Recruit and enroll study patients
?Collect data through beneficial and supportive contact with patients
?Follow all study-related and protocol procedures
?Create and maintain study files
?Maintain screening enrollment and device/drug accountability logs
?Maintain study patient tracking files
?Generate IRB reports to properly document applicable issues, adverse events, protocol deviations, violations & supplemental reports
?Follow all internal regulatory and quality assurance guidelines and work closely with Regulatory and Compliance Officer
?Meet with investigators to ensure communication and quality of data
?Communicate professionally with representatives of sponsoring companies
?Provide excellent customer service and respond to issues and needs
?Prepare for monitoring/auditing visits, work with monitors when on site, and address all inquiries and follow-up as required by policies.
?Perform chart reviews required for data collection
?Assist with drafting policies and procedures for clinical trials execution.
?Maintains strictest confidentiality.

OTHER RELATED DUTIES

?Assist with data collection and entry needs
?Contribute to organizational projects and other tasks that may arise from time to time.

Required Experience

?At least 2 years experience as a clinical study coordinator, experience in spine beneficial
?Strong knowledge of, and rigorous adherence to, FDA and IRB regulations
?Extreme attention to detail
?Good communication skills
?Exhibit flexibility, adaptability, and ability to function on a team
?Good organizational skills


Education Requirements

?Nursing training or other form of medical certification preferred
?CCRC certification beneficial, but not required