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Clinical Research Coordinator RN
4 months ago
POSITION SUMMARY
The Clinical Research Coordinator (CRC) assists the principal investigator (PI) and sub investigators with all aspects of study implementation within the KU Pediatric Hematology Oncology clinic. The CRC will collaborate with the multidisciplinary team in the management of subjects participating in clinical research studies. Conducts studies as assigned, staying within parameters of protocol and regulatory compliance, available resources, and budget.
ESSENTIAL FUNCTIONS:
Duties and Responsibilities:
- Maintains utmost level of confidentiality at all times.
- Adheres to clinic and hospital policies and procedures.
- Coordinates and manages clinical studies according to OHRP and FDA regulations, as well as ICH Good Clinical Practices and IRB requirements.
- Serves as a liaison for clinical staff for clinical trial related management.
- Collect and manage patient and laboratory data for clinical research projects.
- Manage research project databases, develop flow sheets and other study related documents.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Develop tactical study procedures and any necessary study documents not provided by sponsor or IRB.
- Interact with principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Screen and recruit patients based on protocol criteria.
- Explain study protocols, procedures and treatments to patients and families.
- Conduct the Informed Consent process in conjunction with study investigators.
- Ensure that an original copy of any subjects Informed Consent Document is the in the research binders, as well as a copy on the subject's medical record.
- Provide/coordinate the highest level of contact, counseling, and support services.
- A comprehensive knowledge of all assigned protocols.
- Verifies patient eligibility.
- Perform Phlebotomy and IV procedures.
- Coordinates, obtains, processes, and ships all protocol required tissue samples in appropriate media and temperature.
- Maintains research charts for all assigned trials and enrolled patients.
- Maintain copies of all research related correspondence.
- Supports the clinical team in various administrative tasks, encompassing order management, signature verification, patient scheduling, and actively seeks opportunities for process improvement and broader contributions within the organization, to include coordinating with the pediatric sedation unit clerk.
- Understands and follows all Universal Precaution Procedures.
- Understands and follows all HIPAA guidelines and processes to ensure patient confidentiality.
- Reliable Attendance and Punctuality.
- Other duties as assigned.
Education: BSN required
Experience: 2 -5 years’ experience in pediatrics, pediatric hematology oncology, and/or Clinical Oncology Group (COG) background, preferred.
SKILLS & ABILITIES
Computer Skills
Electronic medical records, basic Microsoft Office, spreadsheet management, database management and development.
Certificates & Licenses
Licensed in the State of Kansas as a Registered Nurse (RN)
Must complete KU Human Subjects Protection training module
