Clinical Research Nurse

Northwestern Memorial Healthcare • Chicago, IL

3d

About The Position

The Clinical Research Nurse (CRN) is a registered professional nurse who serves as a liaison between Northwestern University clinical research investigator teams and Northwestern Medical Group. The CRN works collaboratively with the inter-professional team and peers to support the appropriate implementation and conduct of clinical research studies throughout the lifecycle of a protocol. The role adheres to Northwestern Medicine’s mission, values, Code of Ethics, compliance program, applicable policies, and regulatory and accreditation standards.

The CRN coordinates study logistics and provides direct nursing care and clinical assessment for study subjects under the direction of the principal investigator or supervising physician. The position also supports protocol implementation, study visits, participant communication, data quality, regulatory submissions, staff training, and research documentation. Travel between hospital locations where research is conducted is required.

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 or Master of Science in Nursing.
• Three to five years of experience in clinical research trials.
• Certification by the Association of Clinical Research Professional 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, including applicable inpatient admission and discharge, diagnosis, medication administration, study-related tests, and ongoing clinical assessment of study subjects under the direction of the principal investigator or supervising physician.
• Provide input on protocol implementation, including settings, systems issues, and process changes; present information at weekly meetings; and monitor budgets for selected study aspects.
• Attend investigator meetings and coordinate and attend pre-study site visits, study initiation visits, and other monitor or sponsor representative visits when required.
• Arrange procedures and visits performed by external vendors as necessary 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 IRBs.
• Give subjects study participation instructions and serve as their primary contact for study-specific questions, concerns, or events.
• Ensure protocol procedures are completed according to study requirements.
• Collect and document adverse event and serious adverse event data on appropriate forms and report it to the appropriate parties as required by protocols, regulations, and applicable policies and procedures.
• Assure the quality and completeness of source documents to support principal investigator review and approval.
• Ensure accurate, complete, and timely data entry into case report forms using 100% source documentation verification.
• Schedule, lead, and assist with study visits on site and be available during visits to address corrections, questions, and other study or site needs.
• Supervise document retention, security, and destruction where applicable.
• Complete required position, protocol-specific, and health system training.
• 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 preparing or reviewing IRB submission materials, including protocols and consent documents where applicable.
• Travel between hospital locations where research is conducted.
• Perform other job-related functions as assigned.

Benefits

• Tuition reimbursement
• Loan forgiveness
• 401(k) matching
• A wide range of benefits supporting physical, emotional, and financial well-being and protection for unexpected life events

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level