Clinical Research Nurse

Department: MED-Preventive Medicine
Salary/Grade: EXS/8

The target hiring range for this position will be between $75,000 to $85,000 per year. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.

Job Summary

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 data in study source documents and on case report forms. Schedules and tracks study visits. Ensures that study diet/meals are properly administered to participant and provides participant education regarding adherence. Also oversee accountability of data collection devices and provides associated education. Reviews clinical and laboratory data on study participants.

Data

• Responsible for ongoing data collection and maintenance of confidential records. Reviews study forms, files and reports for completeness, accuracy, consistency and compliance (quality control). Ensures appropriate and timely transmission of clinical data to data management center. Responds in a timely manner to requests for data clarifications and queries. The study nurse will assemble medical information (results of physical examination, ECG, vital signs) for review and presentation prior to randomization. The study nurse will review research billing.
• Ensures accurate, complete, and timely data entry into provided database systems using source documentation verification to assist with overall principal investigator review and approval.

Administrative

• Complete credentialing through Northwestern Memorial Hospital to see patients and access the electronic medical record system (Epic). A health screening, covered by Northwestern, will be required as a part of the credentialing.
• Attends investigator's meetings, coordinates and attends pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required.
• Maintains and documents all study-related communication including, but not limited to the principal investigator or supervising physician, study subjects, Sponsor or Sponsor representative(s) and IRB throughout the clinical trial.
• Obtains and documents all adverse event data on appropriate forms and reports adverse event data to the appropriate parties as outlined by the study protocol, regulations and applicable policies and procedures. Notifies principal investigator of any abnormal values and ensures follow-up and reporting of adverse events in accordance with regulatory requirements.

Supervises

• Trains other study specific research staff in collection and reporting of required data, where applicable.
• Manages and acts as supervisor of study personnel. Conduct performance check ins, quarterly reviews and year-end evaluation. Responsible for ensuring performance excellence in study team.

Other

• Travels between hospital locations where research is conducted.

Miscellaneous

• Performs all other functions as related to this job and assigned.

Minimum Qualifications:

• A bachelor's degree in nursing from an accredited nursing program along with 1 years of clinical practice or the equivalent combination of education, training and experience.
• Current license as a registered nurse with the state of Illinois.
• Must complete Collaborative Institutional Training Initiative (CITI) program training in information privacy security, HIPAA, and security and privacy.

Minimum Competencies: (Skills, knowledge, and abilities.)

• 2 years of experience completing clinical procedures such as inserting catheter.
• Ability to work collaboratively within healthcare teams and diverse populations.
• Strong computer skills to include advanced use of Word and Excel software programs, internet, and email.
• Must possess ability to articulate and clearly communicate study information to patients, study team, and other health care professionals
• Attention to detail and highly organized.
• Excellent clinical assessment skills.
• Able to make decisions independently and yet must be team oriented.

Preferred Qualifications:

• Master of Science degree
• Experience in clinical research, especially nutrition research

Preferred Competencies: (Skills, knowledge, and abilities)

• Bilingual ability is a plus

Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process.

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