Coordinates all aspects of multiple complex clinical trials, with a focus on cell and gene therapy, hematology & oncology. Clinical trials include high risk Phase I-III trials under INDs, as well as Phase II/III local and industry sponsored trials. This requires multidisciplinary skills directed towards clinical patient management and safety, protocol administration and compliance, and providing education and training to research staff, clinical staff, medical providers, patients and their families. Incumbent at this level is an experienced professional serving as an expert resource and mentor to other study/protocol staff.
Job Duties â— Extensive application of knowledge of medical conditions and diseases, the nursing scope of practice, clinical research laws, ethics and clinical practice to: Safely and efficiently perform protocol-specific procedures; manage research subjects’ participation in all clinical research settings; problem-solve issues that arise during trial conduct. â— Serve as an expert in drug/product administration and other study treatments to ensure patient safety and compliance with the protocol, institution, and regulatory bodies. Conduct, coordinate and serve as a resource for various aspects of clinical trials from start-up to closeout according to study protocols. â— Contribute to study start-up activities, including site initiation visits, source document and flow sheet creation, beacon order builds, study staff training, and clinical in-services. â— Attend Investigator Meetings and continue to consult with sponsors remotely to revise study logistics, protocols, consents, electronic data capture systems, and other study documents to best reflect clinical practice and minimize patient burden. â— Develop protocol-specific logistics plans in collaboration with project management and clinical staff to operationalize complex cell and gene therapy protocols. â— Patient recruitment, screening, consent, enrollment and necessary registrations. â— Provide education to staff, subjects and families about clinical trials including but not limited to: Treatment, possible side effects and complications of therapy, financial implications of participation, etc. â— Coordinate study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records and personal communications with other healthcare workers. â— Cooperate with quality assurance department to conduct quality control checks. â— Collect & document adverse events and serious adverse events, ensuring reporting of said events to appropriate entities in a timely manner and in accordance with CTO and Sponsor SOPs. â— Collaborate with the study team to ensures timely submission of study/regulatory documentation, including but not limited to: Resolution of monitoring findings, development of annual protocol reports to the NMDP and FDA (as applicable), and reporting to data safety monitoring boards several times a year. â— Recommend and develop corrective action plans, as appropriate (often in collaboration with a regulatory specialist and other members of the study team). â— Serve as an expert regarding study conduct when studies are being monitored or audited by internal or external bodies including local monitors, sponsors, the IRB or FDA. Facilitate regular meetings with the study team including the principal investigator (and co-investigators as applicable), clinical staff, clinical research coordinators, and regulatory specialist(s) to: Discuss the status of patients on clinical trials; protocol-required reporting; areas for improvement; clinical trial development, etc. â— Contribute to the production of research publications and/or presentations of research data. â— Coordinate study close-out activities.
All required qualifications must be documented on application materials.
Required Qualifications: - BS degree in Nursing AND at least 4 years of professional nursing experience or a combination of related education and experience totaling at least 8 years. -Current license to practice as a Registered Nurse in the State of Minnesota. - Must have pediatric or adult oncology/hematology clinical experience OR clinical research experience. - Experience with Microsoft Office and web-based systems for tracking activities, calendaring, and retrieving/updating information. - Demonstrated/documented ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies. - Possess excellent communication skills; verbal and written. - Flexibility with work schedule to accommodate subject visits. *Proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza are required.
Preferred Qualifications: - Experience with BMT. - Experience with EPIC. - Familiarity with the University of Minnesota and MHealth hospitals/clinics. - Ability to integrate clinical care with clinical research to meet the needs of the patient. - Experience with Oncore or equivalent clinical trials management system.
Internal Number: 337466
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.