The Clinical Research Nurse is responsible for coordinating research-related activities for clinical trials conducted at the center. As a Clinical Research Nurse, this individual ensures appropriateness of subjects, supervises data collection and reporting, subject management, and ensures adherence to all regulatory requirements and sponsor protocols. In addition, this individual is responsible for helping to orient new personnel, acting as a resource to research study subjects, physicians, and other clinic personnel.
**Please note: Research study visit may be outside a typical Mon-Fri work week. Research study initiation training may require some travel outside the Chicago metropolitan area.
- Becomes familiar with all protocols assigned. For assigned studies, initiates study start-up activities including study initiation meeting, scheduling subject visits, along with scheduling any outside personnel or tests for these individual visits.
- Evaluates volunteer subjects for potential study qualification in accordance with inclusion/exclusion criteria provided by study sponsor. Assists in subject recruitment as well as acting as a resource for the marketing personnel and referring physicians.
- For qualified participants, initiates medical and social histories, physical exam, and physiological measures as indicated in protocol. Records this data in detail. Schedules study visits as required by protocols.
- Ensures appropriate laboratory, x-ray and other diagnostic examinations are scheduled and completed per study protocol. Oversees any outside services as required.
- Reviews medical, laboratory, and other diagnostic data on study subjects. Notifies principal investigator of any abnormal values or any significant changes in these values. Notifies and follows up with subjects as required.
- Reports serious adverse events to principal investigator and sponsor in a timely manner. Follows up with subjects or subject family members in accordance with requirements.
- Collects data requested by protocol. Ensures accuracy of data obtained. Collates and enters data into subject charts, sponsor case report forms, and/or remote data entry equipment in atimelyand precise manner.
- Ensures that all study drug received in unit is accurately documented and stored in locked location. Ensures that study drug is maintained in appropriate temperature controlled environment. Verifies that all study drugs is correctly labeled, and packaged. Ensures that appropriate study drug is dispensed to subject along with detailed instructions on use. Maintains accurate documentation of study drug receipt/dispensation.
- When studies require other supplies and/or equipment, coordinator will ensure their availability and ensure proper orientation has occurred prior to use.
- Ensures subject compliance with study drug and study visits. Documents all efforts made to retrieve study medication. Notifies sponsor of any deviations from protocol. Whenever possible, obtains exceptions.
- Schedules routine study reviews with sponsor monitors or appointed sponsor representative. Arranges access to all subject records for the indicated time period of review. Allows time to respond to monitor questions and to make correction to case report forms. Promptly responds to sponsor queries.
- Prepares for and completes close out procedures for terminated studies. Ensures all FDA, sponsor, and center regulations have been followed.
- Provides health practices information and education to practice and study subjects regarding medications, diseases, diet, exercise, and any special procedures. Assists patients by providing appropriate referrals to physicians, clinics, or agencies.
- Acts as a liaison for subject/physician telephone calls.
- Assist with training of other center personnel.
- Works with other research coordinators and research assistants to provide back-up replacement during absences, and follow-up as needed.
- Actively participates in clinical meetings, rounds, and departmental meetings.
- Participates in other center activities such as special projects, and any other duties as assigned by supervisor.
- Contributes to the development of the Coordinator Program and Center for Clinical Research as a high performing team.
- Performs other duties as assigned.
- At least an associate's degree in nursing.
- Registered nurse with current licensure in the State of Illinois.
- Excellent clinical assessment skills.
- Detail-oriented and highly organized.
- Ability to understand technical research protocol.
- Excellent problem solving skills.
- Able to make decisions independently and yet must be team oriented.
- Must possess ability to articulate and clearly communicate study information to patients, and other health care professionals.
- Professional demeanor with ability to interact with pharmaceutical/sponsor representatives, regulatory agents, medical center administration, medical staff, peers, and patients.
- BSN degree.
- At least one year of research experience as a clinical research coordinator.
As per Northwestern University policy, this position requires a criminal background check. Successful applicants will need to submit to a criminal background check prior to employment.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes including veterans and individuals with disabilities.