Clinical Research Nurse Manager

University of Colorado

1d•$83,170 - $105,793•Hybrid

About The Position

The Clinical Research Nurse Project Manager is responsible for leading and managing the clinical aspects of Phase I–IV industry-sponsored, cooperative group, and investigator-initiated trials in compliance with study protocols, FDA regulations, and ICH/GCP guidelines. This role ensures studies meet specific goals and timelines while performing and overseeing clinical tasks such as drug administration, phlebotomy, pharmacokinetic sampling, toxicity assessments, EKGs, Holter monitoring, and other protocol-required procedures within scope of practice. The position coordinates communication among project leaders, clinical staff, sponsors, and departments to support successful study implementation and workflow, while collaborating with research nurses to validate treatment plans and provide oversight. Additionally, the role supervises research nursing staff, including daily staffing, education, training, policy development, and process improvement initiatives. Strong communication skills and a commitment to respectful, high-quality service are essential to effectively support study participants, investigators, and the broader research team.

Requirements

Graduation from an accredited school of nursing with a BSN
Five years of clinical research experience
Two years of supervisory experience (can be included in above experience). This can always include charge nurse or equivalent experience.
Candidate must have an active Colorado nursing license or ability to obtain their Colorado license prior to start date.
Please include a copy of your current RN license with your submission.
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 level; 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 is able to 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 ahead, manages time effectively to accomplish tasks.
Technical Skills – Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.
Option 1: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Applicants must meet minimum qualifications at the time of hire.
Please be advised that this position is not eligible now or in the future for visa sponsorship.

Nice To Haves

CCRP – Certified Clinical Research Professional (obtained through SoCRA) or CCRC – Certified Clinical Research Coordinator (obtained through ACRP)
ONS/ONCC Chemotherapy Immunotherapy Certificate

Responsibilities

Submits and/or manages treatment plans through the UCHealth Beacon process and works with assigned staff for completion of the treatment plan.
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
Works with clinical departments to help facilitate research within these areas. Collaborate with hospital departments on clinical research workflows and participate in collaboration meetings as a research representative
Collaborates with hospital departments on identified complex therapies and new treatment modality studies that require significant teamwork in order to effectively treat patients.
Develops program/project goals and communicate goals and outcomes with a variety of stakeholders
Liaises and coordinate with a variety of program/project stakeholders including, but not limited to, program/project sponsors, regulatory agents, pharmaceutical representatives, and clinic/hospital staff
Develops and maintains a variety of reports and communicates and present data to stakeholders.
Develops protocol-specific systems and documents including process flows, training manuals, and Standard Operating Procedures (SOPs)
Perform supervision and management responsibilities for clinical processes conducted by the research nurse team. Duties include, but are not limited to, recruitment, supervision, scheduling, education, and performance management responsibilities.
Schedule and lead weekly team meetings to discuss workloads and team coverage needs
Perform regular one on ones with each team RN to discuss workloads and other needs
Collaborates with hospital staff to ensure tests and procedures required by clinical protocols are performed and documented. 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
May be called upon to perform the following specific tests and procedures specifically related to the research study: a) consenting, b) electrocardiogram, c) blood pressure, pulse, height, weight, pulse oximetry, and temperature measurements, d) phlebotomy and specimen processing and shipping
Collaborates with the clinical team in developing all aspects of patient care.
Assesses patient’s pertinent health history
Rotates through department PK (blood draw) schedule as necessary
Develops and review trial specific treatment (protocol) orders for accuracy and completeness prior to implementation in electronic medical record