RN-Clinical Research Specialist

J  o  b    D  e  s  c  r  i  p  t  i  o  n

JOB INFORMATION

Effective Date:

2/1/2023

Entity:

Wisconsin

Job Code:

790014

Job Title:

RN-Clinical Research Specialist

FLSA Exemption Status:

Exempt

Management Level:

Individual Contributor

JOB SUMMARY

The UW Health RN-Clinical Research Specialist - CRU fosters positive working relationships with clinical and research contacts across multiple specialty areas that traverse UW Health and UW-Madison. They work closely and build relationships with Principal Investigators, Study Specialists and other interdisciplinary study team members, in addition to the Center for Clinical Knowledge Management (CCKM) staff, Information Services staff, Pharmaceutical Research Center (PRC) staff, and the physicians, nurses, and pharmacists who interact with research participants on the Clinical Research Unit (CRU) at UW Health. This position is familiar with UW Health clinical and research policies and procedures and applicable UW-Madison policies. The Clinical Research Specialist functions as the liaison to the interdisciplinary research team and ancillary support departments/organizations to ensure Good Clinical Practice (GCP), Human Subjects Protections (HSP), clinical best practice, and adherence to applicable regulations and policies for all clinical research protocols carried out on the CRU.

The RN-Clinical Research Specialist - CRU facilitates the integration of complex clinical and research workflow discussions and guides decisions to support the safety of our patients/participants and ensure research protocol fidelity is maintained for studies carried out on the CRU. This position will manage the implementation and operationalization of complex research protocols and amendments to existing research protocols on the CRU. Clinical nursing and research expertise is required to ensure proper integration of research in the electronic health record (EHR), inform EHR orders build for both oncology treatment plans and non-oncology order sets, and provide education and at-the-elbow support to providers and study team staff using the EHR. They will lead discussions, organize meetings, and oversee activities to ultimately ensure the timely implementation of research protocols on the CRU. In this capacity, the Clinical Research Specialist serves as the liaison between the clinical, research, and informatics staff, understanding all three realms and the goal of protocol fidelity and research patient/participant safety for research protocols carried out on the CRU.

Day to day activities are moderate to highly complex and overseen by the Nurse Manager (NM) for the Clinical Research Unit at UW Health.

ESSENTIAL DUTIES

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Integrates and balances the principles and philosophy of clinical research and professional nursing care delivery into the clinical research practice setting.

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Assesses feasibility of protocol implementation on the CRU including a detailed evaluation of the nursing and research activities required.

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Maintains a systems mindset to detect upstream/downstream and cross-system impact focusing on the intersection where research processes and clinical care workflows meet.

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Supports CRU direct care RNs in caring for patient/participants on the CRU.

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Manages a portfolio of protocols and projects including new protocol implementation, ongoing support of active protocols, and projects to support CRU operations.

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Establishes workflows required to operationalize research protocols being carried out on the CRU.

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In preparing for implementation of research protocols, plans for resources to coordinate medical, and nursing management of study patients/participants.

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Records and maintains accurate records of study protocol implementation workflows and decisions for studies implemented on the CRU.

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In collaboration with the NM and CNS, provides education and ongoing support to CRU staff for studies being carried out on the CRU.

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Serves as an approachable and responsive point-of-contact for research related questions that come from the UW Health clinical staff, information systems staff, and the UW research community for studies being carried out on the CRU.

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Leads the research orders build process for individual study requests for non-Oncology studies and informs nursing and clinical research practice in the oncology treatment plan review process.

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Maintains a working knowledge of the principles that guide clinical research nursing (participant and study team member safety; participant self-determination; research informed consent; fidelity to the research protocol; regulatory compliance; and research ethics and guiding principles).

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Meets personal continuing education and professional developmental needs.

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Supports and/or participates in research programs approved by the Hospital, Institute of Clinical and Translational Research, and/or the University of Wisconsin-Madison.

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Promotes open and effective communication among staff, medical faculty, PIs, interdisciplinary research teams, and other departments.

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Develops protocol specific Nursing documents to collect study specific data and guide research and clinical care practice ensuring fidelity to the research protocol.

As needed, additional responsibilities reasonably within the scope of duties and physical requirements may be assigned.  ALL DUTIES AND REQUIREMENTS MUST BE PERFORMED CONSISTENT WITH THE UW HEALTH PERFORMANCE STANDARDS AND RESPECT FOR PEOPLE COMMITTMENTS.

X

Clinical

(Select all that apply)

JOB REQUIREMENTS

Bachelor's Degree

Bachelor of Science in Nursing (BSN)

Preferred

2 years

Relevant clinical research nursing experience

Required

• Experience in an academic medical setting

• Project management experience

Preferred

Licensed as a Registered Nurse (RN) in the State of WI or holds a license issued by a jurisdiction that has adopted the nurse licensure compact

Upon Hire

Required

Clinical Research Certification

Preferred

CPR/BLS Certification

Preferred

LICENSE, CERTIFICATIONS, AND REGISTRATIONS MUST BE MAINTAINED PER UW HEALTH POLICY. 

•

In-depth knowledge of profession, clinical workflows, and system processes

•

Demonstrated project management skills

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Excellent communication skills (interpersonal, oral and written)

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Comfortable with an interdisciplinary culture of collaboration

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Knowledge of word processing, data base management, and electronic communication

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Ability to work independently

•

Ability to educate staff, patients, and families

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

☒

Sedentary: Ability to lift up to 10 pounds maximum and occasionally lifting and/or carrying such articles as dockets, ledgers and small tools. Although a sedentary job is defined as one, which involves sitting, a certain amount of walking and standing is often necessary in carrying out job duties. Jobs are sedentary if walking and standing are required only occasionally and other sedentary criteria are met.

Up to 10#

Negligible

Negligible

☐

Light: Ability to lift up to 20 pounds maximum with frequent lifting and/or carrying of objects weighing up to 10 pounds. Even though the weight lifted may only be negligible amount, a job is in this category when it requires walking or standing to a significant degree.

up to 20#

Up to 10# or requires significant walking or standing or requires pushing/pulling of arm/leg controls.

Negligible or constant push/pull of items of negligible weight

☐

Medium: Ability to lift up to 50 pounds maximum with frequent lifting and/or carrying objects weighing up to 25 pounds.

20-50#

10-25#

Negligible-10#

☐

Heavy: Ability to lift up to 100 pounds maximum with frequent lifting and/or carrying objects weighing up to 50 pounds.

50-100#

25-50#

10-20#

☐

Very Heavy: Ability to lift over 100 pounds with frequent lifting and/or carrying objects weighing over 50 pounds.

Over 100#

Over 50#

Over 20#

Other - list any other physical requirements or bona fide occupational qualifications not indicated above:

Over 50 lbs.

UW Health does not require, nor does it expect that its employees lift more than 50 lbs unassisted. Objects in excess of 50 lbs should be lifted or moved with mechanical means or through a team lift. Employees in patient care areas are expected to utilize mechanical lifts and adhere to the "Use of Mechanical Lifts (Liko)" policy in the Patient Services Policy and Procedure Manual.

Note: The purpose of this document is to describe the general nature and level of work performed by personnel so classified; it is not intended to serve as an inclusive list of all responsibilities associated with this position.

THE EMPLOYEE MUST BE ABLE TO COMPLETE ALL PHYSICAL REQUIREMENTS OF THE JOB WITH OR WITHOUT AN APPROVED ACCOMODATION. Note: The purpose of this document is to describe the general nature and level of work performed by personnel so classified; it is not intended to serve as an inclusive list of all responsibilities associated with this position.