LifeBridge Health
Research Coordinator
The Clinical Research Coordinator (CRC), under the guidance and supervision of the Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. Responsibilities include: Preparing regulatory documents and monitoring regulatory activities for assigned clinical trials. Preparing protocol for initial and continuing Institutional Review Board (IRB) review; submitting protocol revisions and amendments for IRB review; submitting Serious Adverse Events reports and Investigational Drug Safety Reports to the IRB; maintaining IRB correspondence documentation for study sponsor and cooperative group audits. Preparing initial Informed Patient Consent forms for study participation; preparing form revisions when requested by study sponsor and submitting for IRB review. Managing the day to day regulatory/protocol maintenance operations of the assigned clinical trials. Assisting with the implementation of the clinical research agreement, study budget and investigator contract, review and ARB submission; responsible for annual protocol/research agreement renewal coordination. Qualifications/requirements: Experience: Required: 1-3 years related experience. Education: Preferred: Associate's Degree Biological sciences, medical technologist, or related background preferred. Clinical Experience preferred including phlebotomy, specimen collection, and vital signs. Licenses And Certification: Basic Life Support Certification.
The Clinical Research Coordinator (CRC), under the guidance and supervision of the Principal Investigator (PI), ensures the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. Responsibilities include: Preparing regulatory documents and monitoring regulatory activities for assigned clinical trials. Preparing protocol for initial and continuing Institutional Review Board (IRB) review; submitting protocol revisions and amendments for IRB review; submitting Serious Adverse Events reports and Investigational Drug Safety Reports to the IRB; maintaining IRB correspondence documentation for study sponsor and cooperative group audits. Preparing initial Informed Patient Consent forms for study participation; preparing form revisions when requested by study sponsor and submitting for IRB review. Managing the day to day regulatory/protocol maintenance operations of the assigned clinical trials. Assisting with the implementation of the clinical research agreement, study budget and investigator contract, review and ARB submission; responsible for annual protocol/research agreement renewal coordination. Qualifications/requirements: Experience: Required: 1-3 years related experience. Education: Preferred: Associate's Degree Biological sciences, medical technologist, or related background preferred. Clinical Experience preferred including phlebotomy, specimen collection, and vital signs. Licenses And Certification: Basic Life Support Certification.