Oncology Clinical Research Nurse - JS Hope Tower - F/T Days

About the role

At Hackensack Meridian Health, our team members are the heart of what makes us better. We help our patients live better, healthier lives and support one another to succeed. With a culture rooted in connection and collaboration, our employees are integral to advancing our mission to transform healthcare and serve as a leader of positive change.

The Clinical Research Nurse coordinates and oversees clinical research operations for assigned clinical trials, participating in assessing, planning, implementing, and evaluating compliant patient care. The role works under the general supervision of the principal investigator responsible for the clinical trials.

Responsibilities

• Assists the principal investigator in preparing proposed clinical trials by reviewing trial protocols, coordinating with departments providing resources, and ensuring proper notification and distribution of trial information.
• Ensures timely submission of protocol revisions, informed consents, continuing reviews, and serious adverse events to the appropriate IRB of record.
• Acts as a liaison between principal investigators and sub-investigators on all regulatory issues and protocol changes.
• Collaborates with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluate potential competition with other protocols.
• Reviews studies with the principal investigator and/or clinical research coordinator to outline standard of care and research costs, finalizing budget drafts with the budget coordinator.
• Recruits and evaluates potential study patients, scheduling required appointments and interviews with the clinical research coordinator.
• Identifies the needs of the patient population and modifies care delivery accordingly (e.g., age, culture, hearing/visual impairments), communicating at the patient’s level.
• Reviews medical records for potential study patients, ensuring documentation of laboratory test results, procedures, and patient progress per protocol guidelines.
• Instructs patients, caregivers, physicians, and staff on patient care, available trials, treatments, and side effects.
• Assists with the consent process, ensuring patients understand clinical trials and obtaining written informed consent.
• Educates study patients on informed consent procedures and HIPAA authorization.
• Documents patients' medical history, including past treatments, medical conditions, and medication history per protocol guidelines.
• Performs nursing assessments and monitors patient progress during clinical trials, tracking responses via toxicity flow sheets, medication flow sheets, and progress notes.
• Maintains accurate, complete, and up-to-date records for each patient in applicable systems (e.g., electronic medical record, clinical trial management system).
• Evaluates and develops patient education materials, providing instructions on drug administration and creating study-specific calendars.
• Plans appropriate patient care under the direction of a physician or advanced practice nurse.
• Notifies the principal investigator of adverse events and serious adverse events, reporting them to sponsors and IRB according to established timelines.
• Coordinates research activities, including scheduling laboratory tests, radiology testing, and other medical exams.
• Performs and/or oversees clinical duties such as EKGs, processing/shipping of blood serum and urine, and communicating results to the principal investigator or advanced practice nurse.
• Reviews and processes all Safety Reports (INDs, SUGARs) with the principal investigator per institutional policies.
• Acts as the principal investigator’s representative, communicating with sponsors, IRB, and other medical personnel as needed.
• Ensures appropriate billing for clinical trial-related activities and reconciles drug study account records with research finance personnel.
• Prepares for sponsor monitor site visits, ensuring all supporting documentation is available and resolving issues identified during visits.
• Develops case report forms and/or databases for physician-initiated studies as needed.
• Assists the principal investigator in preparing publications and works with analysts to evaluate collected data.
• Provides education to departments and clinical areas involved in the study.
• Attends research meetings and conferences as required, participating in staff meetings and in-service education.
• Adheres to HMH organizational competencies and standards of behavior.
• Performs other duties and/or projects as assigned.

Requirements

• BSN required (applies to team members hired or transferred into the role on or after March 31, 2024; those hired prior may have an associate degree in Nursing or diploma). Advanced master’s degrees in nursing satisfy the BSN requirement.
• Minimum of 3 years of clinical nursing experience or 1 year of clinical nursing experience with an additional 2 years of clinical research experience.
• Adheres to the American Nurses Association standards.
• Strong attention to detail and customer service focus.
• Excellent communication, organizational, presentation, documentation, and interpersonal skills.
• Ability to work independently or in a team and handle multiple deadline-driven tasks in a dynamic environment.
• Proficient computer skills, including Microsoft Office and/or Google Suite platforms.
• Review and comply with all relevant HMH and business unit policies, local, state, and federal laws and regulations.

Qualifications

• NJ State Professional Registered Nurse License (required).
• AHA Basic Health Care Life Support HCP Certification within 60 days of entering the position (required).
• National Certification in area of specialty (preferred when eligible).
• Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Certified Clinical Research Coordinator (CCRC) (preferred).