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University of Rochester Clinical Research Project Nurse, Neurosurgery - 231779 in Rochester, New York

Clinical Research Project Nurse, Neurosurgery Job ID 231779

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Temporary Opening

Full Time 40 hours Grade 044 Department of Neurosurgery

Schedule

8 AM-4:30 PM

Responsibilities

POSITION SUMMARY:The position is for an experienced research nurse to join a dynamic, cross-functional team working in the field of translational clinical research with a focus on surgical study populations. The research project nurse will be part of an adjudication committee assisting in determining eligibility for a sponsored global registration Ph3 trial. They will also assist in coordinating other industry- and investigator-initiated research studies. Applicants must be able to work independently, have professional RN licensure, and familiarity with clinical research.

NOTE: This position is an end-dated position and is expected to last until June 2024 , subject to the availability of grant funding.

SUPERVISION AND DIRECTION RECEIVED:

Under the direct supervision of the Principal Investigator and oversight from the Vice Chair for Clinical Research

TYPICAL DUTIES:

Adjudication Committee (70%)

  • In a timely manner, reviews documentation received from sites in study database to ensure receipt of all required information. (25%)

  • Conducts preliminary review to ascertain if subject meets eligibility requirements to be included in trial. (25%)

  • Thoroughly reviews clinical information and forwards on to expert clinicians for final eligibility determination, assisting with answering questions they may have as applicable. (5%)

  • Maintains high degree of knowledge on study protocol, Standard Operating Procedures (SOPs), and chronic pain syndrome under study. (5%)

  • Maintains continuous communication with adjudication committee and all relevant stakeholders. (10%)

Clinical Research and Data Management (20%)

  • Supports other clinical research studies in the Department of Neurosurgery as needed with a focus on inpatient studies, including:

  • Study Visits: Recruits, consents, schedules, and conducts research subject visits in accordance with study protocol, coordinating these visits with the Principal Investigator. Draws blood, processes samples, and performs testing such as ECG and treadmill tests, depending on the protocol. Coordinates and documents dispensing and returning of study drugs/materials.

  • Regulatory Oversight: Oversees and manages the regulatory details for assigned research studies. Manages and submits study applications, amendments, and continuing reviews for IRB approval (local and central).

  • Data Management: Develops and manages databases (e.g., EDC, REDCap) for research studies. Ensures data entered and queries responded to in a timely manner.

  • Liaison: Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolve issues, and enhance collaboration.

Continuing Education (5%)

  • Demonstrates accountability for continuous learning related to clinical research.

  • Keeps current with study-specific training, including understanding specific details of study protocol, all relevant sponsor and institutional policies, standard operating procedures, and guidelines.

  • Facilitates and participates in training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and state polices and laws, institutional certifications, industry standards and best practices, and trends in relevant therapeutic areas.

Other projects and job duties as assigned (5%)

QUALIFICATIONS:

  • RN degree required (maintaining professional RN licensure is expected) and at least two years of experience in nursing. At least one year of human subject research coordination highly preferred. Or an equivalent combination of education and experience.

  • Phlebotomy training highly preferred.

  • Professional research coordinator certification (e.g., SoCRA or ACRP) preferred.

  • Knowledge of word processing, spreadsheets, and electronic data capture (EDC) software preferred.

  • Must be independent and organized, have excellent communication skills, strong attention to detail, and strong interpersonal skills.

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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