Clinical Research Nurse, SOM, Stravitz-Sanyal Institute for Liver Disease

Duties & Responsibilities

• Be directly responsible for study coordination and regulatory management of an assigned portfolio of clinical research studies covering a variety of diseases and conditions.
• Cover all study specific imaging needs with internal & external Principal Investigators.
• Ensures compliance with each study’s protocol by providing thorough review and documentation at each subject study visit.
• Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.
• Perform pre-scan checks including medication allergies, safety screenings/evaluations of all MRI participants for contraindicated devices, and clinical labs as indicated.
• Consults with appropriate research staff on participant devices and contraindications as needed.
• Obtain participant vascular access, vital signs as needed and other clinical duties in caring for research imaging participants during visit.
• Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects.
• Work with research staff to monitor participants post-injection while following all reaction protocols per ACR guidelines.
• Provide accurate and timely data collection, documentation, entry, and reporting in either internal and sponsor databases.
• Work with technologists on protocol questions, and participate in other operational tasks within the Imaging Center as needed including administrative duties such as maintaining inventory, staffing operations, and participant scheduling.
• Work with Associate Director of Clinical Trials to ensure best practice guidelines are followed for the research participant in areas such as study activation, study coordination, data management, and records management.
• Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as required.
• Understand and adhere to all IRB requirements, Human Subjects protection regulations, and all aspects of IRB approved protocols.
• Ensure site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
• Ensure compliance with research protocols, by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability.
• Maintain appropriate training, licensure and certifications per job requirements.
• Engage with staff and departmental leadership to streamline research workflow and operational efficiencies, while ensuring compliance to MRI and PET/CT policy and procedures.
• Perform quality assurance procedures and implement process improvement changes as required.
• Serve as an ongoing resource for providing information and expert advice on clinical research issues.

Qualifications

• Active clinical RN licensure is required for duties.
• Bachelor's degree or equivalent applicable combination of training, education and experience.
• At least 2 years of relevant clinical experience and at least one (1) year clinical trials research experience preferred.
• Ability to work around an MRI machine and handle biological samples containing radioactivity.
• Current active BLS certification.
• Ability to work independently, think critically, and use professional and ethical judgment in all aspects of work.
• Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.