The Research Nurse Coordinator II is responsible for all activities associated with clinical study coordination, subject recruitment/enrollment, data management/integrity, regulatory compliance, project/study evaluation and interfacing with participants and family members. Coordinates the clinical logistics of the study, and works in tandem with the Research and/or Clinical Nurse who work to provide hands-on clinical care to research participants. Utilizes clinical nursing background and extensive research protocol knowledge to serve as a liaison between nursing staff, Principal Investigator, other research staff, and study participants. Assists with the education of staff, and provides general oversight of research portfolio as it pertains to the clinical coordination of the studies.

Primary Duties and Responsibilities

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  Responsible for clinical study activities, coordination, adherence to protocols and serves as a liaison between study participants, Principal Investigator (PI), and other research staff.
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  Provides educational services to research participants and family regarding study participation, participants current clinical condition, and or disease process.
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  Assesses and documents adverse events as reported by research participants, works closely with PI to document according to department process (grade, attribution, treatment, etc.), and reports to regulatory and sponsor as required.
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  Records research data where assessed or reported by patient (i.e. symptoms of treatment).
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  Creates and presents education materials to the interdisciplinary team on study requirements.
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  Collaborates with the interdisciplinary team to create and communicate a plan of care that allows for safe and effective collection of clinical research data.
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  Triages patient by phone and provides clinical information to the patient.
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  Completes and documents study participant enrollment, assessment/reassessment, education, and follow-up activities and ensures protocol is followed.
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  Coordinates study participant tests and procedures as required.
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  Prepares data spreadsheets for Investigator and/or department.
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  Performs oversight of research portfolio as it pertains to the clinical coordination of the studies.
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  Assists with the education of staff.
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  May assist with grant proposals, publication preparation, and presentations.
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  May process, ship, track or otherwise handle research specimens.
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  Demonstrate an understanding of the required steps to ascertain study feasibility at the site level
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    Attend and Participate in Site Qualification Calls/Visits
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  Demonstrate an in-depth understanding of a study protocol and examine the steps necessary to comply with the schedule of events/screening and eligibility requirements
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  Demonstrate the ability to assess and document subject eligibility
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    Note source documents required to support protocol inclusion/exclusion criteria
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  Demonstrate the ability to create study tools/plans that enable the collection of data within study visit windows
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    Draft and QC study visit checklists
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  Demonstrate the ability to set up workflows/processes across departments (outside the cancer center) for study logistics
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    Draft and QC Protocol Flowsheets/Yellow Folders
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  Demonstrate the ability to complete RNIs independently
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  ACRP/SOCRA (or equivalent) certification required within one year of hire/promotion. Maintenance of certification (membership, dues, etc.) must remain current
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  Train and mentor CRC I. Has an efficient and high quality level of work
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  Assist with study start up tasks at the direction of the DRG PM, including PRMC submission of new protocols for the DRG/Team

Requirements:

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  Associate Degree/College Diploma Nursing
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  3 years - Clinical nursing experience
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  2 years - Clinical research experience

Preferred:

• Bachelor's Degree Nursing or Health Science

Licenses:

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  RN State License California - Upon Hire
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  Basic Life Support

Physical Demands:

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

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