Clinical Research Coordinator

 

Responsible for verifying that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete and verifiable from source documents. Additionally, the Clinical Research Coordinator makes sure that the conduct of the trial is in compliance with currently-approved protocol/amendments(s) and with applicable regulatory requirements.

 

 

• Responsible for the management of clinical trials, including: analysis of potential patient recruitment, preparation of trial-related documentation, ensuring the safety and proper conduct of the trial, organizing IRB/Ethics committee submissions, and continued communication between all parties involved.
• Maintain files, including: IRB approvals, CV of investigators and study personnel, clinical investigator brochures, protocols, case report forms, consent documents, material shipping orders, letters of agreement, lab information, investigator and site correspondence, and schedules of payment.
• Maintain records of initial sponsor correspondence, records of IRB submissions, amendments, budgets, contracts, and/ or approved consents. Monitor updates and closures online.
• Manage patient recruitment strategies to increase patient accrual, including: investigator meetings, advertising, letters to appropriate physicians, being familiar with and distributing patient selection criteria, etc. Educate potential subjects on the details of the study.
• Follow study management policies and procedures regarding the registration of all study candidates. Prepare patient packets, including: consent with updated IRB, eligibility checklist, protocol treatment calendar, and lab certificates & reference ranges. Coordinate the subjects treatment scheduling process, as required by protocol.
• Complete Case Report forms for lab draws, proper storage of specimens, and preparation of shipping and receiving of specimens. Maintain, submit and track completed Case Report forms. Ensure that queries generated during cleaning are responded to in a timely manner.
• Collaborate with clinical staff and Principle Investigator to ensure tests and procedures that are required by clinical protocols are performed and documented, and charges from pharmacy are billed correctly.
• Initiate treatment and specimen collection. Maintain and document adequate follow-up with patients, physicians, and sponsors. Monitor and re-check nursing dosages to ensure the patient receives treatment per protocol and reports to SWOG organization.
• Recognize and follows protocol for legal reporting of adverse events to appropriate parties (e.g. Principle Investigator, SWOG organization).
• Attend investigator-coordinator meetings, initial orientations, study audits, and closeout visits.
  

 

 

• N/A