This individual is a member of a research team, consulting with healthcare professionals and staff and providing direct research care coordination to patients/families. In this role, one will coordinate and execute research protocols in a clinical setting, utilizing Good Clinical Practice (GCP) and Human Subjects Research Protection standards.
Coordinates research projects and clinical trials.
Identifies potential study volunteers
Consult with providers
Manage research participant visits and follow up activities according to study protocol
Collects data and reports to Principal Investigator conducting study
Analyze/evaluate data as needed for patient safety, protocol compliance and completion of study documentation
Coordinates patient care as related to a specific research project or clinical trial
Performs research and clinical nursing duties that are broad in nature and may require design and development of data collection techniques and a thorough knowledge of the specialty, to include research compliance.
Provide clinical research assistance to providers and constituents performing clinical research.
Follow GCP (Good Clinical Practice) guidelines in the conduct, performance and recording of clinical research, support principal investigator (PI) compliance with same.
Act as resource for protocol development and budget preparation.
Basic level of understanding of CMS billing compliance regulations.
Study start-up activities; site initiation visits, document template creation, study staff training, clinical in-services
Oversee and maintain study/regulatory documentation (engaging with and/or delegating to others as needed)
Translate protocol required activities into flow sheets and patient care orders
Manage or participate in subject recruitment, screening, consent, enrollment, and necessary registrations (EMR)
Responsible for continuity of subject participation from beginning of clinical research study to the completion of study.
Manage study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records and personal communications with other health care workers.
Interview subjects according to protocol specific visit requirements to include telephone follow-up, data collection and reporting.
Perform non-invasive protocol procedures, as applicable
Collect and process specimens or delegate appropriately (blood, urine, saliva)
Participates in production of research publications or presentation of research data.
Utilizes the nursing process and nursing standards to prevent or manage actual / potential research participants problems in all clinical care research settings, educates staff, subjects, and their families about protocols, treatment, possible side effects and complications
May provide patient care for research patients
Identifies and assesses adverse events; responsible for subject protocol triage and symptom management.
Administers medications and treatments as required by protocol.
Communicates significant changes in subject status with appropriate staff.
Report all work time on the monthly tracking document and update Subject Tracking Forms in the organization's business systems and clinical trial management systems.
In accordance with GCP and protocol, provide services, assessments, or interventions in accordance with all relevant policies, procedures and practice guidelines.
Delegate direct and indirect research activities to appropriate personnel based on needs, condition, and potential for risk/harm, complexity of the activity and predictability of the outcome.
Communicates with constituents and customers about cardiovascular sponsored clinical trials and their processes.
Ensures that IRB committee recommendations are communicated to sponsors and staff and implemented in a timely and effective manner.
Communicates with sponsor regarding patient consent forms, approval letters and other required forms
Maintains communications with research staff, IRB, IDS Pharmacy, Fairview Research Administration and sponsors on the status of studies.
Performs other tasks in support of institution and leadership.
Understands and correctly acts on the needs of internal and external customers.
Attends staff meetings and other meetings as required, and prepares reports and updates as required.
Education: Minimum Education : Associate degree from an accredited school of nursing
Preferred Education : Bachelors degree in nursing or health-related scientific field of study
Experience: Minimum Experience : Two years experience in a research setting or two years clinical experience in rare disease populations.
Preferred Experience: Two years experience within rare disease research.
Additional Requirements :Excellent customer service skills, proficient in the English language, good attention to detail, ability to problem solve effectively, ability to follow policies and procedures and excellent communication skills. Working knowledge and skills of Microsoft applications (Word, Access, Excel)
Together with the University of Minnesota and University of Minnesota Physicians we have created M Health Fairview. M Health Fairview is the newly expanded collaboration among the University of Minnesota, University of Minnesota Physicians, and Fairview Health Services. The healthcare system combines the best of academic and community medicine — expanding access to world-class, breakthrough care through our 10 hospitals and 60 clinics.
Fairview Health Services (fairview.org) is an award-winning, nonprofit health system providing exceptional care across the full spectrum of health care services. Fairview is one of the most comprehensive and geographically accessible systems in the state, with 10 hospitals—including an academic medical center and long-term care hospital—serving the greater Twin Cities metro area.
Its broad continuum also includes 60 primary care clinics, specialty clinics, senior living communities, retail and specialty pharmacies, pharmacy benefit management services, rehabilitation centers, counseling and home health care services, medical transportation, an integrated provider network and health insurer PreferredOne. In partnership ...with the University of Minnesota, Fairview’s 32,000 employees and 2,400 affiliated providers embrace innovation to drive a healthier future through healing, discovery and education.