Clinical Research Nurse Specialist
19 hours ago
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 research operations for all assigned clinical trials, working under the general supervision of the principal investigator.
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.
- Recruit and evaluate potential study patients, schedule required appointments and interviews, and work with the clinical research coordinator to ensure timely completion of study activities.
- Review medical records for potential study patients, ensure documentation of laboratory test results and procedures, and follow guidelines set forth by the protocol sponsors.
- Assist the principal investigator with consent process, ensuring study patients understand clinical trials and obtain written informed consent.
- Document study patient's medical history, perform nursing assessments, and monitor study patient's progress during clinical trials.
- Maintain accurate, complete, and up-to-date records on each patient participating in a clinical trial protocol.
- Notify the principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.
- Report all serious adverse events to the sponsor and IRB of record according to established timelines.
- 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.
- 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.
- National Certification in area of specialty preferred when eligible.
- NJ State Professional Registered Nurse License
- BLS/CPR certification by American Heart Association is required within 60 days of hire.
- Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
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