Research Nurse Program Specialist (Principal Professional – Level III) Hybrid - .5 FTE

University of Colorado

3d•Hybrid

About The Position

As a member of the research team, this position is responsible for conducting key aspects of research for Phase I-IV industry-sponsored, co-operative group and/or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. The person in this position is accountable for meeting study-specific goals and timelines.

Requirements

A bachelor’s degree in biological sciences, nutrition, nursing, health, human services, social sciences or a directly related field from an accredited institution.
RN License required (Current state nursing license or RN license from a participating state in the National Licensure Compact)
Three (3) years of medical/surgical or oncology nursing experience
Applicants must meet minimum qualifications at the time of application.
Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Nice To Haves

Experience with Epic and information data systems.
CCRP – Certified Clinical Research Professional (obtained through SoCRA) or CCRC – Certified Clinical Research Coordinator (obtained through ACRP)
OCN – Oncology Certified Nurse (obtained through ONS)
Bachelor of Science in Nursing (BSN)
Knowledge of common pharmaceutical terminology.
Attention to Detail – Ability to interpret and master complex research protocol information; work is accurate, and details are not overlooked.
Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
Interpersonal Skills – Ability to establish and maintain effective working relationships with employees at all levels; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality.
Customer Service – Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
Complex Problem Solving – Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
Adaptability – Adapts quickly to change and can manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods.
Planning and Organizing – Sets priorities, anticipates obstacles when planning, manages time effectively to accomplish tasks.
Technical Skills – Experienced professional able to utilize technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology. Experienced with Epic Beacon treatment plan development.

Responsibilities

Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies.
Submits and/or manages treatment plans for all disease sites within the CCTO, through the UCHealth Beacon process, and works with assigned staff for completion of treatment plans including both new studies and amendment changes.
Understands and follows regulations for appropriate validation and build process for treatment plans and can prioritize workload to meet deadlines.
Performs clinical research informatics by researching and observing integration with information technology to improve workflow in all clinical departments where research is performed.
Participates in process re-engineering initiatives and provide informatics support to ensure safe and effective implementation of research studies.
Utilizes internal and external resources to maintain up to date knowledge of current trends and issues in research, nursing practice, healthcare informatics, training techniques, regulatory standards, and organizational policies and procedures. Attends required meetings with Epic Beacon developers.
Collaborates with research and clinical professionals such as Clinical Research Managers, Project Managers, pharmacists, and UCH unit leaders to ensure tests and procedures required by the research team are performed and documented effectively in electronic medical records. These include, but are not limited to vital signs, phlebotomy, specimen processing, EKG’s, drug administration, Infusions, pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures.