Clinical Research Nurse

Northwestern Memorial Healthcare•Orland Park, IL

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 interprofessional teams and peers to support appropriate implementation and conduct of clinical research studies throughout the lifecycle of a protocol. The role reflects Northwestern Medicine’s mission, vision, and values and complies with its ethics, compliance, policy, regulatory, and accreditation requirements. The CRN coordinates research protocols and provides direct nursing care to study participants under the direction of the principal investigator or supervising physician. Responsibilities include coordinating study visits and procedures, supporting investigators and sponsors, maintaining study documentation and data, and ensuring study activities comply with protocol requirements and Good Clinical Practice. The position 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’s or Master’s 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 participants, including applicable inpatient admission and discharge, diagnosis, medication administration, study-related testing, and ongoing clinical assessment under the direction of the principal investigator or supervising physician.
  • Provide input on protocol implementation, including setting and systems issues and process changes; present information at weekly meetings and monitor selected study budget aspects.
  • Attend investigator meetings and coordinate and attend pre-study site visits, study initiation visits, and other monitor or sponsor representative visits as required.
  • Arrange procedures and visits performed by external vendors and coordinate medical needs and coverage for protocol-related procedures.
  • Schedule and lead in-house protocol meetings to review study procedures, staffing, and visit flow.
  • Maintain and document study-related communications with investigators or supervising physicians, participants, sponsors or sponsor representatives, and the IRB.
  • Provide study participation instructions and serve as the primary contact for participants' study-specific questions, concerns, or events.
  • Ensure protocol procedures are completed according to study requirements.
  • Collect and document adverse event and serious adverse event information on appropriate forms and report it as required by the protocol, regulations, and applicable policies and procedures.
  • Ensure the quality and completeness of source documents to support principal investigator review and approval.
  • Enter accurate, complete, and timely data into case report forms (CRFs) using 100% source documentation verification to support principal investigator review and approval.
  • 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 role, 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 in preparing or reviewing materials for IRB submission, including protocols and consent documents where applicable.
  • Travel between hospital locations where research is conducted.
  • Perform other related functions as assigned.

Benefits

  • Competitive benefits, including tuition reimbursement, loan forgiveness, and 401(k) matching.
  • A wide range of benefits intended to support employees’ physical, emotional, and financial well-being and provide protection for unexpected life events.
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