Fairview Health Services Research Nurse in St. Paul, Minnesota

Overview

This position is 80 hours per two weeks during standard business hours Monday - Friday.

Assists investigators by managing multi-center and investigator- initiated clinical trial study activities, performing clinical services and providing expertise in study development and research processes. Study management duties will include, but it is not limited to, education, patient enrollment and assessment, and project management in accordance with Federal and State regulations, IRB requirements, within the scope of nursing practice and Good Clinical Practice (GCP) guidelines. This position will work on clinical trials with investigators throughout the HealthEast Care System.

Responsibilities

  • Patient population against enrollment requirements, Fit with current research portfolio, Availability of research staff, Required equipment and external resources

  • Participates in site qualification visit and site initiation meeting

  • Conducts detailed analysis of study protocol to support budget/contract negotiations

  • Develops study management plan and determine study team member responsibilities

  • Identifies and recommends start-up enrollment goals and recruitment strategies Creates study-specific tools and materials for protocol implementation

  • Collaborates with team members in preparing regulatory documents, including IRB application, informed consent, and recruiting materials

  • Educates internal and external parties about new studies, providing guidance in understanding and implementing study protocols

  • Ensures that the well-being of research subjects is safeguarded and that subjects rights are protected

  • Coordinates and participate in a variety of complex activities involved in the collection, documentation and reporting of clinical research data (e.g., CV lab procedures, vascular studies, wound care, etc.)

  • Screens patient medical records for potential study participation

  • Conducts the informed consent process with potential research subjects in accordance with all regulatory, ethical and Institutional Review Board (IRB) requirements

  • Organizes the day-to-day conduct of research activities for assigned studies Manages source documentation and accurate case report forms (CRFs) for each study subject that record all observations and data obtained during the study

  • Serves as primary liaison with principal investigator, staff, internal/external resources and sponsor regarding patient care issues and progress of the study

  • Conducts ongoing assessment of subjects health status

  • Participates in the design and development of protocols, proposals and associated budgets

  • Participates in sponsor study initiation meetings

  • Participates in the writing of scientific papers

  • Facilitates abstract presentations at scientific meetings

  • Creates case report forms and study specific documents

  • Performs comprehensive review of literature as the knowledge base for practice decisions and research endeavors

  • Participates in external clinic and community relationship development

  • Stays current with clinical nursing skills, clinical research issues, state and federal regulatory requirements, and Good Clinical Practice guidelines

  • Provides leadership and/or support for projects that promote, improve, or enhance the work of the research division (e.g., facilitate conference presentations, provide IIT audits/monitoring, coordinate media relations activities, and perform SOP development and revision)

  • Provides training for new personnel who will be involved in planning, implementation and/or ongoing management of clinical studies

  • Maintains knowledge of, and complies with, all relevant laws, regulations, policies, procedures and standards

  • Actively participates in creating and implementing improvements

  • Performs other responsibilities as needed/assigned

Qualifications

  • Associate's degree in Nursing required

  • Bachelor's degree in Nursing preferred

  • Registered Nurse MN (RN) through the MN Board of Nursing required

  • Either Clinical Research Coordinator Certification (CCRC) or Certified Clinical Research Professional (CCRP)

  • Clinical Research Coordinator Certification (CCRC) through Association of Clinical Research Professionals preferred

  • Certified Clinical Research Professional (CCRP) through Society of Clinical Research Associates preferred

  • Advanced Cardiac Life Support (ACLS) through American Heart Association preferred

  • Basic Life Support (BLS) preferred

  • 2 years Clinical Research Nurse experience

  • 1 to 5 years research experience

  • 2 years of nursing with strong cardiology experience preferred

  • Acute care, critical care, cardiovascular lab, and/or electrophysiology experience preferred

  • Knowledge: Knowledge of research and clinical trial operations and implementation Knowledge of anatomy, physiology, and pathophysiology of the heart preferred

  • Skilled in specialized computer software

  • Ability to use more advanced functions, formulas and other special elements of the specific program or application

  • Gathers and integrates critical information, recognizing and addressing underlying assumptions of others, to arrive at effective solution

  • Breaks down problems into simple tasks or activities

  • Analyzes relationships among several parts of a situation

  • Makes timely, informed decisions that take into account the facts, goals, constraints and risks

  • Relates well to all kinds of people, builds rapport easily, builds constructive and effective relationships, uses diplomacy and tact, can defuse even a high-tension situation comfortable

  • Observes and collects pertinent data and/or clinical findings to enhance patient outcomes

  • Provides patient educational information appropriate to the developmental level, learning needs, readiness, cultural values, and beliefs of patients and families

  • Ability to review and analyze relevant information from various sources to develop new informatio

  • Ability to identify primary and secondary authorities to validate the research

  • Partners with teams effectively to maximize performance, utilizing communication skills, facilitation skills, and knowledge of team dynamics and adapting to change

About HealthEast

At HealthEast, our patients are our neighbors and we are dedicated to their, and our, optimal health and well-being. We are guided by our faith-based heritage, a call to healing that respects the dignity and culture of every person. We empower our patients with user-friendly access to their health information, dependable service, and affordable, high-quality care.

We put new, more efficient models of care into practice, allowing our 7,500 employees and 850 physicians to focus on what’s important: providing compassionate health care that puts the patient and their needs first. With 14 clinics, home care, a medical transportation center, and four hospitals — Bethesda Hospital, St. John’s Hospital, St. Joseph’s Hospital, and Woodwinds Health Campus — we provide excellent family health and specialization, including primary, maternity, orthopaedics and post-acute care.

Job ID 2018-11094

Category Nursing

Contract Status ND

FTE 1.00

Shift Days

HealthEast is an Equal Opportunity Employer. HealthEast will not discriminate in public accommodation, or employment on the basis of race, color, creed, religion, national origin, sex, marital status, status with regard to public assistance, membership or activity in a local commission, disability, sexual orientation, gender identity or expression, age or genetic information.