Clinical Research Nurse

About the role

The Clinical Research Nurse is responsible for coordinating and overseeing clinical research operations for all assigned clinical trials and participates in assessing, planning, implementing and evaluating compliant patient care in clinical research trials. The Clinical Research Nurse carries out the research and works under the general supervision of the principal investigator responsible for the clinical trials.

Responsibilities

• Aids in the preparation of proposed clinical trials by reviewing trial protocols, contacting departments providing resources, and notifying appropriate departments.
• Safeguards all protocol revisions, informed consents, continuing reviews, and serious adverse events by submitting them to the appropriate IRB of record in a timely manner.
• Acts as a liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
• Collaborates with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluate potential competition with other protocols.
• Reviews study budgets with the principal investigator and/or clinical research coordinator, finalizing the budget draft with the budget coordinator.
• Recruits and evaluates potential study patients, schedules required appointments and interviews, and identifies patient needs and modifies care accordingly.
• Reviews medical records for potential study patients and ensures they include necessary documentation.
• Instructs potential study patients, caregivers, physicians, nurse clinicians, and other staff on aspects of patient care, treatments, and side effects.
• Affixes informed consent to study patients and documents the consent process.
• Documents study patient’s medical history and monitors their progress during clinical trials.
• Maintains accurate, complete, and updated records on each patient participating in a clinical trial protocol.
• Educates study patients on drug administration and other medical information, creating study-specific calendars.
• Plans for study patient’s appropriate care under the direction of a physician or advanced practice nurse.
• Notifies principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.
• Reports all serious adverse events to sponsor and IRB of record according to established timelines.
• Coordinates research activities such as scheduling laboratory tests, radiology testing, and other medical exams.
• Performs and/or oversees various clinical duties including EKGs, processing/shipping of blood serum, urine, and communicating results to PI and/or APN.
• Reviews and processes all Safety Reports (INDs, SUGARs) as per institutional policies and procedures.
• Attends research meetings and conferences as required.
• Provides education to all departments and clinical areas where study is performed.
• Attends staff meetings and in-service education of nursing and medical staff.
• Other duties and/or projects as assigned.

Qualifications

• Bachelor of Science in Nursing (BSN) required. (Applicable to team members hired or transferred into the Clinical Research Nurse position on or after March 31, 2024. Team members hired or transferred prior to March 31, 2024 require a minimum of an associate in Nursing or diploma of Nursing degree.) Note: Advanced masters degree in nursing programs satisfy the BSN requirement (ie Associates to MSN).
• Minimum of 3 years 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 is required.
• Excellent communication, organizational, presentation, documentation, and interpersonal skills are required.
• Ability to work independently, or in a team, and handle multiple deadline-driven tasks in a dynamic environment is essential.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
• Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Education, Knowledge, Skills and Abilities Preferred

• National Certification in area of specialty preferred when eligible.

Licenses and Certifications Required

• NJ State Professional Registered Nurse License.
• AHA Basic Health Care Life Support HCP Certification within 60 days of entering position.

Licenses and Certifications Preferred

• Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).