Clinical Research Nurse

Northwestern Memorial Healthcare•Chicago, IL

8d•$41 - $65

About The Position

The Clinical Research Nurse is a registered professional nurse who reflects Northwestern Medicine’s mission, vision, and values and follows its Code of Ethics, compliance program, policies, and applicable regulatory and accreditation standards. The nurse serves as a liaison between Northwestern University clinical research investigator teams and Northwestern Medical Group, collaborating with interprofessional teams to support the appropriate implementation and conduct of clinical research protocols throughout their lifecycle. The role coordinates study logistics and visits, provides direct nursing care to research subjects, monitors their clinical status, ensures protocol procedures and documentation are complete, and supports communications among investigators, participants, sponsors, and the IRB. The nurse also contributes to protocol implementation, study budgets, staff training, research records, and IRB submissions, and travels between hospital locations where research is conducted.

Requirements

Bachelor’s degree or equivalent experience.
Licensed as a Registered Nurse.
Two years of experience managing all aspects of clinical research trials, with in-depth knowledge of protocol requirements and Good Clinical Practice.
Intermediate computer and internet knowledge.
Excellent customer service and patient care skills.
Meticulous organizational skills.
Excellent written and verbal communication abilities.

Nice To Haves

Bachelor of Science in Nursing or Master of Science in Nursing.
Three to five years of experience in clinical research trials.
Certification by the Association of Clinical Research Professionals or the Society of Clinical Research Associates.
Involvement in external professional organizations, such as the Oncology Nursing Society or nursing committee cooperative groups.
Obtain and maintain OCN certification within six months of eligibility if not already certified.

Responsibilities

Facilitate, maintain, and coordinate logistical aspects of assigned study protocols with research staff in accordance with Good Clinical Practice, standard operating procedures, nursing practices, and sponsor requirements.
Provide direct nursing care to research patients, including inpatient admission and discharge where applicable, diagnosis, medication administration, applicable study-related tests, and ongoing clinical assessment under the direction of the principal investigator or supervising physician.
Provide input on protocol implementation, including settings and system issues, and present information at weekly meetings; monitor budgets for selected aspects of research studies.
Attend investigator meetings and coordinate and attend pre-study site visits, study initiation visits, and other visits by monitors or sponsor representatives when required.
Arrange procedures and necessary visits performed by external vendors for study conduct.
Schedule and lead in-house protocol meetings to review study procedures, staffing, and visit flow.
Schedule and coordinate medical needs and coverage for protocol-related procedures.
Maintain and document study-related communications with investigators or supervising physicians, subjects, sponsors or sponsor representatives, and the IRB.
Give subjects instructions for study participation and serve as their primary contact for study-specific questions, concerns, or events.
Ensure all protocol procedures are completed according to study requirements.
Obtain and document adverse event and serious adverse event data on appropriate forms and report it to appropriate parties as required by protocols, regulations, and policies.
Ensure the quality and completeness of source documents to support principal investigator review and approval.
Ensure accurate, complete, and timely entry of data into case report forms using 100% source documentation verification.
Schedule, lead, and assist with study-related on-site visits and be available during visits for corrections, questions, and other study or site needs.
Supervise document retention, security, and destruction where applicable.
Complete position-related training, including protocol-specific training and Health System policies and procedures.
Train other study-specific research staff in required data collection and reporting where applicable.
Maintain research files, design forms as needed, report findings as appropriate, and assist with preparation or review of IRB submission materials, including protocols and consent documents where applicable.
Travel between hospital locations where research is conducted.
Perform other functions related to the job as assigned.