The Lillehei Clinical Research Unit, under the Cardiology division is looking to hire an exceptional nurse to help coordinate and manage clinical trials with a focus in structural heart, resuscitation science, and interventional cardiology. This exciting opportunity is responsible for overall research program management which includes coordinating high risk phase II trials, support locally held IND/IDE trials, as well as phase III industry sponsored trials. The position requires multidisciplinary skills directed towards clinical patient management and safety, protocol administration, providing education and training to research staff, clinical staff, medical providers, patients and their families.
Serves as the primary contact in the LCRU for research within the sub-specialty and is responsible for facilitating research ideas within the scope of the sub-specialty program. Assists investigators in bringing a research idea from concept to actuality, including (but not limited to): access to feasibility information, resources needed, protocol development, budget and regulatory information, laboratory or specialized subject testing, development of necessary tools, statistical consultation, and arranging collaborations to advance and test the idea. (Continues this research support from study initiation to study closeout), including (but not limited to): subject recruitment, study organization, on-going subject assessment, data collection and documentation, analysis, and presentation of data.
Job Duties/Responsibilities: 30% Manages and coordinates subject participation in research protocols • Successfully screens and recruits potential clinical trial subjects by pre-screening clinics and/or admissions, planning and facilitating data base searches, networking with internal/external partners and advertising. • Independently coordinates the informed consent process. • Applies extensive knowledge of cardiovascular conditions and diseases, the scientific method, clinical research laws, ethics and clinical practice to inform independent decisions to solve problems or trouble-shoot issues for subjects participating in protocols. • Utilizes professional nursing techniques and knowledge to perform protocol specific procedures and/or treatments. • Initiates on-going and continuous independent assessments of subject safety, based on knowledge of the drug/device and the disease of study throughout the trial. • Provides consistent and clear communication with subject, Investigator(s) and the clinical care team to ensure protocol compliance and subject safety. • Plans and delivers education to subjects and/or families about the study and disease process. • Acts as a subject advocate.
30% Provides Professional Clinical Research Expertise to University Faculty Conducting Research • Provides expertise and guidance to investigator(s) regarding protocol feasibility, potential conflicts of interest, regulatory compliance, resource options, subject population, timelines, and budget. • Directs and/or prepares Human Subjects Protection Program application, annual review, safety reports to meet federal and safety guidelines. • Provides expert knowledge regarding federal regulations to facilitate and expedite “Humanitarian/Compassionate Use” drug/device exemptions. • Assumes responsibility for directing the proposed study through the channels required for research approvals; judiciously follows the proposed study until approvals are obtained. • Manages, organizes and/or creates all essential documents, including regulatory files, source documents, study communications, drug/device accountability and required logs (training, monitoring site signature, etc.). • Ensures adherence to the Federal Code of Regulations within the investigator’s clinical trial portfolio. • Advises investigator(s) regarding study progress; provides updates on study issues. • Informs the investigator(s) of any safety issues or subject problems. • Communicates effectively with partners in research both internal and external to the University, such as the Sponsor, the Contract Research Organization, Fairview partners, and Regulatory authorities. • Collaborates with investigator(s) to deliver data results in abstracts, case studies, publications, manuscripts, and presentations.
25% Independently facilitates the successful implementation of Cardiology protocols in multiple research settings. • Interprets complex protocols and applies the scientific process and the specific body of knowledge to effect safe and efficient protocol implementation. • Develops protocol implementation plans, establishing protocol priorities, assessing needs and identifying potential risks. • Implements protocol from pre-initiation through study close out with an ongoing priority of subjects safety while mitigating subject risks • Utilizes the nursing process, an on-going process of planning, assessing, implementing, and evaluating based on a body of knowledge. • Applies the Federal Code of Regulations, GCP standards, ethical guidance (Belmont Report, Declaration of Helsinki) and University and/or Fairview policies while performing or supervising protocol-specific procedures. • Establishes collaborative relationships with research partners using effective communication, teaching/mentoring, and directing team members relative to their roles within the protocol. • Manages accurate study data collection and entry adhering to HIPAA regulations; using charts, correspondence, electronic medical records and communication with other health care workers. • Maintains proficiency for multiple electronic case report form data bases. • Works with study monitors on an ongoing basis to ensure data compliance and integrity. • Successfully manages multiple investigators and multiple protocols. • Identifies and reports protocol related Serious Adverse Event (SAE), Adverse Events (AE), protocol deviations, as required by federal regulations. • Provides educational in-services to faculty, staff, clinical partners etc. Contributes to education of other clinical research professionals.
15% Provides program leadership and manages the successful operations of the program • Leads the sub-specialty team, providing expertise, knowledge, and guidance/direction to research staff and colleagues. • Provides input in the budget planning and preparation, recommends/changes in operational budget; reviews, analyzes, and initiates re-negotiation as necessary. Review and approves study specific invoices. • Develops and cultivates relationships with multiple departments within the institution to execute high complexity protocols. • Provides expert advice for improvements in clinical and research operations to Fairview and the University; develops, recommends, and validates tools to efficiently and effectively conduct research. • Compiles reports/presentations on program activity; analyzes historical data and trends; determines impact on existing and future operations. • Delegates protocol required activities and provides supervision of study related work flow involving multiple people within Lillihei Clinical Research Unit and external units in order to manage study protocol outcomes. • Oversees quality control and internal monitoring activities within the sub-specialty. • Educates, mentors, and guides undergraduate and graduate students in the field of clinical research.
Required Qualifications: Bachelor's degree in Nursing and 6 years of nursing experience (or advanced degree with 4 years of experience). Current license to practice as a Registered Nurse in the state of Minnesota. Experience with Word, Outlook, 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.
Preferred Qualifications: Master's degree in Nursing. Cardiovascular nursing experience. Research coordinating experience. Interventional Cardiology experience. Structural Cardiology experience. Experience with EPIC system. Ability to integrate clinical care with clinical research to meet the needs of the patient.
Internal Number: 335159
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