Registered Nurse 2 Research

Job Description

The Department of Neurological Surgery is a dynamic treatment training and discovery driven enterprise dedicated to improving quality of life through leadership in care and research that restores neural function. Our clinical care research and training mission keeps us at the forefront of neuroscience discovery. Housed within the Department of Neurological Surgery the Clinical Trials Innovation (CTI) group has an outstanding opportunity for a full-time Registered Nurse 2 - Research to support a diverse portfolio of clinical trials and observational studies conducted with these patients.

This position will work collaboratively with the CTI group to contribute to various activities in support of our trials and studies including but not limited to conducting examinations vitals blood draws administration of trial treatment/medication in accordance with the approved protocols evaluation of study outcomes and acting as the lead regulatory staff member working in tandem with CTI leadership and other faculty investigators for all compliance IRB audit annual review purposes. This position will also be required to learn the various electronic data capture systems utilized for the trials and studies along with the other CTI staff to provide support and oversight into the needed data entry and documentation for each initiative.

The successful candidate will have a background in clinical trials and observational patient studies and an ability to work collaboratively in hospital and clinic settings with diverse faculty and research teams across multiple care streams that patients interface with through the course of their treatment. The successful candidate will also have strong independent judgement and be able to monitor and oversee tasks completed by the CTI research coordinators to assure proper alignment with all regulatory requirements. The position reports directly to the Vice Chair of Research and maintains workspace at both the University of Washington Medical Center Montlake (UWMC) and Harborview Medical Center (HMC).

This role requires attention to detail efficient organizational skills and the ability to manage multiple projects and work in fast-paced clinical environment at times. The successful candidate will exhibit strong ability to take study protocols and develop facility specific SOPs for efficient and successful addition they will demonstrate ability to think independently while coordinating resources with the CTI team and managing progress on all trial/study patient recruitment and follow up assessment milestones across the CTI portfolio.

The necessary attributes to successfully meet all the demands of this position include Epic competency strong clinical trial experience 21 CFR Part 11 regulation experience (AKA Part 11 compliant experience) project management experience and an ability to handle a high volume of confidential medical information while assisting CTI leadership in overseeing staff to assure project deadlines are met across multiple studies. The ideal candidate will have a high level of integrity and professionalism an ability to work successfully in a team environment and an ability to build productive working relationships inside and outside of the department and hospital wide while keeping abreast of research objectives policies and standards in order to effectively contribute to the CTI group priorities and needs.

The CTI group is funded primarily through industry sponsors and grant funds and its essential that trials and studies be conducted in accordance with established milestones to maintain compliance with all regulatory and funding partners.

Job Responsibilities

RN Research Activities 90%

Work with CTI leadership and/or principal investigators to manage and implement trials and studies. Current trials include tumor trials acute neurotrauma trials spine studies functional neurosurgery studies and neurovascular trails and studies. For these trials and studies this position will:

• Administer all vitals blood draws medications at UWMC and HMC and help the team conduct the study assessments and outcomes through the longitudinal study visits.

• Learn maintain and help train CTI staff on the various electronic database systems for these trials and studies such as RedCap Trialmaster QuesGen among others to provide required centralized data collection and reporting.

• Learn and complete patient required assessments for trials and studies supported by the CTI group.

• Plan and implement the nursing protocol for the medical activities of each trial or study.

• Write and maintain all human subjects applications consents and study documents in compliance with FDA regulation

• Act as the primary point for all regulatory reviews study audits site initiation visits of study monitors study closures etc

• Assist CTI leadership in evaluating the effectiveness of the trial treatment strategies and therapeutics as well as provide support along with CTI leadership and study Investigators for secondary medical history screening of prospective patients identified by preliminary screening completed by the CTI research coordinators.

Other Duties 10%

• Provide regulatory guidance and support for departmental research activities that may arise with neurological surgery residents and fellows so all trainee activities are conducted and maintained in compliance with all requirements.

Minimum Requirements

• Bachelors Degree in nursing or a relevant field AND Two (2) years of experience at the Registered Nurse 1- Research level.

• Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements such as a license certification and/or registration.

• Current license to practice as a registered nurse in the State of Washington.

Additional Requirements

• Excellent verbal written and interpersonal communication skills

• Experience working with patients for research purposes or clinical practice in clinics and on the wards.

• Professional maturity with the ability to work collaboratively across teams and hospitals

• Experience with general database systems for research such as REDCap or other online data acquisition application

• Experience with implementing and conducting Part 11 compliance requirements.

• Ability to work effectively independently and provide regulatory oversight to trails and studies.

Desired Qualifications

• Familiarity with UW Medicine clinical enterprise

• Prior experience practicing nursing with patients with various neurological conditions

• Advanced knowledge of REDCap

• Prior clinical trails experience implementing both therapeutic and device trails

Compensation Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Temporary or Regular

FTE (Full-Time Equivalent):

Union/Bargaining Unit:

About the UW

Working at the University of Washington provides a unique opportunity to change lives on our campuses in our state and around the world.

UW employees bring their boundless energy creative problem-solving skills and dedication to building stronger minds and a healthier return they enjoy outstanding benefits opportunities for professional growth and the chance to work in an environment known for its diversity intellectual excitement artistic pursuits and natural beauty.

Our Commitment

The University of Washington is committed to fostering an inclusive respectful and welcoming community for all. As an equal opportunity employer the University considers applicants for employment without regard to race color creed religion national origin citizenship sex pregnancy age marital status sexual orientation gender identity or expression genetic information disability or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process contact the Disability Services Office at or .

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.