SocClin Research Specialist-CEDAS
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Job Location:
Chapel Hill, NC - USA
Hourly Salary:
$ 28 - 32
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Summary
The Center for Gastrointestinal Biology and Disease ( CGIBD ) is seeking an experienced part time Clinical Research Coordinator ( CRC ) to support ongoing gastrointestinal (GI) clinical trials. The CRC will support multiple investigator initiated and sponsor led clinical trials and will work closely with Principal Investigators study teams sponsors and regulatory bodies to ensure high quality compliant study conduct. Research Study Execution * Collect study data per protocol using a variety of methods including surveys clinical observations electronic medical record abstraction and biospecimen collection. * Perform clinical tests and study procedures in accordance with study protocols and required training. * Accurately record study data and complete electronic or paper case report forms in compliance with Good Clinical Practice ( ICH GCP ) and ALCOA C principles. * Maintain high standards of data quality and documentation integrity throughout the study lifecycle. Regulatory & Clinical Research Operations Support * Create maintain and organize essential study documentation (e.g. delegation of authority logs training records). * Develop submit and maintain regulatory applications and study materials including informed consent forms and recruitment materials. * Identify gather and retain required regulatory documentation in accordance with sponsor IRB and institutional requirements. * Prepare for coordinate and participate in monitoring visits; resolve queries and support implementation of corrective actions as needed. * Track document and report protocol deviations and adverse events; participate in root cause analyses (RCAs) and corrective and preventive action ( CAPA ) development. * Maintain study supplies and coordinate biospecimen processing tracking and shipment when applicable. Participant Management * Screen and recruit research participants per protocol and institutional SOPs. * Coordinate and support participant visits and follow up activities. * Track study enrollment and participant accrual metrics. Project & Study Start Up Support * Contribute to study start up activities including document development system setup and coordination with sponsors and internal teams. * Participate in site initiation visits study start up meetings and close out visits. * Assess study needs and implement strategies to optimize visit flow recruitment and participant retention. * Assist with the development of study source documents checklists data collection tools and internal workflows. * Independently communicate with sponsors regulatory authorities and UNC offices regarding study related matters escalating issues as appropriate.
Work Schedule
Monday Friday 8:00 AM 5:00 PM other times as needed
The Center for Gastrointestinal Biology and Disease ( CGIBD ) is seeking an experienced part time Clinical Research Coordinator ( CRC ) to support ongoing gastrointestinal (GI) clinical trials. The CRC will support multiple investigator initiated and sponsor led clinical trials and will work closely with Principal Investigators study teams sponsors and regulatory bodies to ensure high quality compliant study conduct. Research Study Execution * Collect study data per protocol using a variety of methods including surveys clinical observations electronic medical record abstraction and biospecimen collection. * Perform clinical tests and study procedures in accordance with study protocols and required training. * Accurately record study data and complete electronic or paper case report forms in compliance with Good Clinical Practice ( ICH GCP ) and ALCOA C principles. * Maintain high standards of data quality and documentation integrity throughout the study lifecycle. Regulatory & Clinical Research Operations Support * Create maintain and organize essential study documentation (e.g. delegation of authority logs training records). * Develop submit and maintain regulatory applications and study materials including informed consent forms and recruitment materials. * Identify gather and retain required regulatory documentation in accordance with sponsor IRB and institutional requirements. * Prepare for coordinate and participate in monitoring visits; resolve queries and support implementation of corrective actions as needed. * Track document and report protocol deviations and adverse events; participate in root cause analyses (RCAs) and corrective and preventive action ( CAPA ) development. * Maintain study supplies and coordinate biospecimen processing tracking and shipment when applicable. Participant Management * Screen and recruit research participants per protocol and institutional SOPs. * Coordinate and support participant visits and follow up activities. * Track study enrollment and participant accrual metrics. Project & Study Start Up Support * Contribute to study start up activities including document development system setup and coordination with sponsors and internal teams. * Participate in site initiation visits study start up meetings and close out visits. * Assess study needs and implement strategies to optimize visit flow recruitment and participant retention. * Assist with the development of study source documents checklists data collection tools and internal workflows. * Independently communicate with sponsors regulatory authorities and UNC offices regarding study related matters escalating issues as appropriate.
Work Schedule
Monday Friday 8:00 AM 5:00 PM other times as needed
Required Experience:
Staff IC
About Company
The University of North Carolina at Chapel Hill, the nation’s first public university, is a global higher education leader known for innovative teaching, research and public service. A member of the prestigious Association of American Universities, Carolina regularly ranks as the best ... View more
