Registered Nurse - Clinical Research Nurse (CRN)

Carenest Health Services•Fullerton, CA

13d

About The Position

The Clinical Research Nurse coordinates clinical research protocols and activities in consultation with the Investigator, Research Program Manager, protocol, and sponsor. The position works in compliance with federal regulations, good clinical practice (GCP), Institutional Review Board (IRB) guidelines, departmental standard work, and the nurse’s scope of practice. The role is both patient-facing and administrative and supports clinical trials centered on Rheumatology. This is a six-month position posted based on a six-month grant; the nurse is expected to begin with a strong foundation in clinical research knowledge. The nurse provides patient and family education, obtains informed consent, collects and documents protocol data, supports regulatory submissions, recruits and enrolls participants, and maintains study records and supplies. The role also includes working with physicians and allied health professionals across departments, managing monitor visits and audits, and supporting research staff as needed. The position requires maintaining patient confidentiality and information security, cooperating with risk-management activities, maintaining clinical competence within the applicable license or certificate, and providing age-appropriate care and communication to the patient population served.

Requirements

Registered Nurse; the role must be performed within the employee’s legal scope of practice and license or certificate.
Two years of experience required, as stated in the posting.
Strong foundation of clinical research knowledge at the start of the position.
Working knowledge of clinical research activities and applicable federal regulations, GCP, IRB guidelines, and departmental standard work.
Ability to provide age-appropriate care and communication and assess age-specific patient needs.
Ability to maintain confidentiality and security of patient and other information.

Nice To Haves

Two or more years of clinical research experience preferred.
Three or more years of subspecialty nursing experience in an acute care or ambulatory setting preferred.
CCRC certification preferred.
Rheumatology experience highly preferred.
Oncology experience highly preferred.
Inpatient studies experience highly preferred.
CAR-T experience highly preferred.
Experience with IDX, Meditech, NextGen, or PACS is a plus.
Bilingual English/Spanish is a plus.

Responsibilities

Coordinate research activities with the Investigator, Research Program Manager, protocol, and sponsor in a safe, efficient, and cost-effective manner.
Train and assist CRC I/II staff as necessary.
Ensure study binders for each participant are complete and accurate.
Attend investigators’ meetings as required.
Provide patient and family education about study requirements and investigational agents’ risks, benefits, and side effects; provide information on the Investigational Subjects Bill of Rights and use and disclosure of Protected Health Information; and obtain written informed consent as directed by the Investigator.
Perform protocol-directed data collection with accurate, thorough source documentation and submit data to the sponsor promptly.
Research and network regarding potential new studies.
Perform regulatory functions for existing and upcoming studies.
Work with the Principal Investigator and Research Program Manager to prepare submissions to a local or central IRB.
Recruit and enroll patients in studies in collaboration with physicians and allied health professionals across multiple departments.
Manage monitor visits and audits.
Maintain organized records of research activities, including regulatory documents, source documents, tracking logs, and correspondence required by sponsors and standard work.
Maintain secure and accurate inventory of study medications and supplies.
Ensure current temperature logs for research medications, delegate this task as appropriate, and promptly report temperature excursions to appropriate personnel.
Participate in St. Jude Heritage Healthcare work groups, meetings, and activities as assigned.
Know the legal scope of practice and maintain clinical competence in skills covered by the applicable license or certificate.
Support the team, follow through on assigned tasks, and perform other duties as assigned.
Demonstrate age-appropriate care, assessment, communication, and knowledge of relevant community resources.
Maintain confidentiality and security of information and data within the position’s scope.
Cooperate fully in risk-management activities and investigations.