CRC, RN

Minneapolis heart institute foundation•Minneapolis, MN

7d•$65,000 - $75,000•Onsite

About The Position

At the Minneapolis Heart Institute Foundation (MHIF), your dedication fuels innovation, transforms patient care, and helps shape the future of cardiovascular medicine. As a Research Nurse, your role goes beyond the bedside—you become a vital connection between patients and research that leads to life-saving discoveries. In support of the Minneapolis Heart Institute Foundation (MHIF) mission, Clinical Research Coordinators (CRC) provide support, coordination and leadership for research studies that may involve industry sponsored Phase I, II, III, and IV clinical trials, drug, biologic, device, government-funded clinical research and investigator-initiated clinical research. They ensure smooth, accurate progress of clinical studies in accordance with all legal and regulatory standards from the planning and approval stages through study completion and post-study closure. CRC’s assist with documentation for Institutional Review Board (IRB) submissions, recruit and screen study participants and help facilitate their continued participation; abstract data from electronic medical records (EMR) and other sources; collect, submit and maintain study data and regulatory documents; ensure compliance with study protocols and participate in initial budget discussion for clinical trials.

Requirements

CRC’s with experience are required to pass CCRC certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) within two years of date of hire.
A valid Minnesota Registered Nurse (RN) license.
Bachelor’s degree.
A minimum of 1 year clinical research coordination experience or equivalent combination of research and clinical experience.
Proficiency in MS Office, MS Outlook and electronic medical record systems (Epic).
Strong interpersonal skills with the ability to work with others as a team and in support of a positive work culture.
Ability to work effectively managing multiple projects.
Strong attention to detail.
Must be able to pass institution’s compliance requirements, EMR (Epic) and Collaborative Institutional Training Initiative (CITI). (Incumbents assigned to National Institutes of Health (NIH) trials must be able to pass NIH mandated training prior to the start of the study.)
Basic Life Support (BLS) certification.

Nice To Haves

Previous cardiovascular clinical and/or research experience preferred.
Experience with clinical trial management systems (CTMS) and document management systems.
Active licensure via Diploma, Associate’s, or Bachelor’s degree programs in a healthcare-related field.
NIHSS Certification

Responsibilities

Determines subject eligibility based on protocol Inclusion and Exclusion criteria.
Demonstrate the informed consent process was correctly followed.
Assures all human participant’s questions and concerns are addressed continuously throughout study participation in a timely fashion.
Assesses subject participation at each protocol required visit (consent is a continual process).
Properly identifies, documents and assist with Institutional Review Board (IRB) mandated reporting.
Screens, recruits, and manages retention of study participants.
Conducts and documents informed consent process prior to any protocol required testing.
Completes Case Report Forms (CRF) in a timely fashion and with accuracy.
Maintains accurate test article accountability and reconciles as needed.
Completes subject visit requirements per study protocol.
Follows Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP) guidelines, IRB Policies and Procedures.
Follows Minneapolis Heart Institute Standard Operating Procedures (SOP) as well as abiding by Allina Health SOP requirements.
Develops and maintains source and study documents for study lifecycle.
Develops and ensures compliant processes with study protocols.
Achieves enrollment goals accounting for variables beyond control.
Supports planning, development and budgeting for clinical trials during study start-up as delegated by leadership.
Ensures adherence of MHIF Conflict of Interest (COI), confidentiality policies and Employee Code of Ethics.
Resolves data queries per study timeline.
Ensures accuracy of all study data abstracted from medical records and other sources.
Contributes to Research and/or MHIF organizational quality improvement initiatives as delegated by MHIF leadership.
May contribute to dissemination of research by drafting text and/or charts for abstracts, manuscripts and poster/Power Point presentations.
Manages other projects and completes various tasks as assigned by MHIF Leadership.