Clinical Research Nurse

Clinical Research Nurse

This position is funded through March 31st, 2027. The position is for a Clinical Research Nurse who will assist in implementing a National Institute of Health funded research program named Nutrition for Precision Health (NPH), powered by the All of Us Research Program. NPH will enroll a diverse subset of All of Us participants. The participants will contribute measures across multiple domains (e.g., metabolism, behavior, social determinants of health) that are purported to predict individual responses to foods and dietary patterns.

The overarching goal of NPH is to develop algorithms that predict human response to foods, nutrients, food components, and dietary patterns. Under general supervision and according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and/or general instruction, directly supports the research initiatives of NPH at Northwestern University. Collaborates with the principal investigators, physicians, and clinical research team in implementing this federally funded multi-center clinical trial.

Responsible for coordinating research studies from the initiation of the study to its completion, including but not limited to implementing clinical and non-clinical study procedures. With strict adherence to the study protocol, this person conducts eligibility assessments, collects data and maintains confidential research records, provides study patient management according to protocol and regulatory requirements. The Clinical Research Nurse practices within the scope of the Illinois Nurse Practice Act to ensure the delivery of comprehensive, high quality, individualized nursing care, based upon knowledge and experience, the nursing process and leadership skills.

The selected candidate is responsible for all aspects of coordinating a clinical trial as delegated by the Principal Investigator under all applicable policies, procedures and regulations. The Clinical Research Nurse reports to a Supervisor who provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.

Work may extend beyond the central NU/NM campus to NM affiliates for targeted initiatives.

Specific Responsibilities:

• Technical screen, enroll, and follow a highly diverse population designed to study participants over the course of a controlled clinical study as outlined in assigned research protocols.
• The study nurse will perform physical examinations and biosample collection on participants according to protocol.
• Provides direct nursing patient care including, but not limited to inpatient admission and discharge, where applicable, diagnosis, administration of medications, and performance of applicable clinical study-related tests as well as maintaining continual assessment of study subjects under the direction of the principal investigator, supervising physician and or project director.
• Coordinates the implementation of clinical research protocols at Northwestern and subsites.
• Works with sponsors, study staff, laboratory staff, data managers, pharmacists, clinic staff, investigators, and other departments to develop and implement protocol-specific standard operating procedures.
• Coordinates clinical and non-clinical study start-up activities including organization of study medical records and coordination of required laboratory and clinical evaluations.
• Performs patient recruitment and evaluates subjects for potential study qualification in accordance with protocol eligibility criteria, including: medical record review, interviewing, clinical and laboratory evaluations, obtaining informed consent.
• The study nurse will collect information necessary for reporting serious adverse events (including details of the hospitalization).
• Provides ongoing monitoring of patients in clinical research protocols. Reviews medical and social histories, clinical evaluations and ensures laboratory and other procedures are ordered by the PI as required by protocol.
• Records/abstracts…