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Clinical Research Nurse

2 months ago


Hackensack, New Jersey, United States Hackensack Meridian Health Full time
Job Summary

We are seeking a highly skilled Clinical Research Nurse to join our team at Hackensack Meridian Health. The successful candidate will be responsible for coordinating and overseeing clinical operations of clinical trials, participating in assessing, planning, implementing, and evaluating compliant patient care in clinical research studies.

Key Responsibilities
  • Assist the principal investigator in preparing proposed clinical trials by reviewing trial protocol, contacting relevant departments, and ensuring timely submission of protocol revisions, informed consents, and continuing reviews.
  • Act as liaison between principal investigators and sub-investigators on regulatory issues and changes within the protocol.
  • Interact with regulatory specialists and principal investigators on regulatory issues and changes within the protocol.
  • Collaborate with the principal investigator, clinical research coordinator, and clinical team to review studies for feasibility and evaluate potential competition with other protocols.
  • Recruit and evaluate potential study patients, and work with clinical research coordinator to schedule required appointments and interviews.
  • Identify patient needs and modify care to meet those needs, communicating with patients, caregivers, and healthcare providers as necessary.
  • Review medical records for potential study patients and ensure documentation of laboratory test results and procedures.
  • Instruct patients, caregivers, and healthcare providers on aspects of patient care, available trials, treatments, and side effects.
  • Assist with consent process, ensuring patients understand clinical trials and obtain written informed consent.
  • Document patient medical history, including past medical/surgical treatments, significant medical conditions, and medication history.
  • Perform nursing assessments and monitor patient progress during clinical trials.
  • Maintain accurate, complete, and up-to-date records on each patient participating in a clinical trial protocol.
  • Evaluate and develop patient education materials and provide instructions on drug administration and medical information.
  • Plan for patient care under the direction of a physician or advanced practice nurse.
  • Notify principal investigator of adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.
  • Report serious adverse events to sponsors and IRB of record according to established timelines.
  • Coordinate research activities, including scheduling laboratory tests, radiology testing, and other medical exams.
  • Perform and/or oversee clinical duties, including EKGs, processing/shipping of blood serum, and communicating results to PI and/or APN.
  • Review and process Safety Reports (INDs, SUGARs) as per institutional policies and procedures.
  • Act as principal investigator's representative as appropriate, communicating with sponsors and their representatives, the IRB, and other medical personnel.
  • Ensure study patient's clinical trial-related activities are billed appropriately and reconcile drug study account records with research finance personnel.
  • Prepare and assist for sponsor monitor site visits and ensure all supporting documentation records are adequate and available for the visit.
  • Develop case report forms and/or databases for physician-initiated studies as needed.
  • Assist the principal investigator in preparing for publication, working with analysts and assisting with queries related to data to evaluate the significance of collected data.
  • Provide education to all departments and clinical areas where study is performed.
  • Attend research meetings and conferences as required.
  • Participate in staff meetings and in-service education of nursing and medical staff.
Requirements
  • BSN required (Note: this applies to team members hired or transferred 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.)
  • Minimum of 3 years clinical nursing experience or 1 year of clinical nursing experience with an additional 2 years of clinical research experience.
  • NJ State Professional Registered Nurse License.
  • AHA Basic Health Care Life Support HCP Certification within 60 days of entering position.
  • 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.
  • National Certification in area of specialty preferred when eligible.
  • Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC) preferred.