Clinical Research Nurse
3 weeks ago
Transforming Healthcare through Clinical Research
At Hackensack Meridian Health, we are committed to advancing our mission to transform healthcare and serve as a leader of positive change. As a Clinical Research Nurse, you will play a critical role in coordinating and overseeing clinical research operations for all assigned clinical trials.
Key Responsibilities:
- Assist the principal investigator in preparing proposed clinical trials by reviewing trial protocol and ensuring appropriate departments are notified.
- Ensure timely submission of protocol revisions, informed consents, continuing reviews, and serious adverse events to the IRB of record.
- Act as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
- Interact with regulatory specialists and principal investigators on all regulatory issues and changes within the protocol.
- Participate in the review of studies for feasibility and evaluate potential competition with other protocols prior to submitting study.
- Review study with principal investigator and/or clinical research coordinator to finalize budget outlining standard of care and research costs.
- Recruit and evaluate potential study patients, and work with clinical research coordinator to schedule required appointments and interviews.
- Identify the needs of the patient population served and modify and deliver care that is specific to those needs.
- Review medical records for potential study patients and ensure that medical records include documentation of all laboratory test results and procedures and progress of study patients.
- Instruct potential study patients, designated caregiver, physicians, nurse clinicians, and other ancillary staff members involved in the care of the patient on aspects of patient's care, available trials, treatments, and side effects.
- Assist investigator with consent process assuring study patients understand clinical trials and obtain written informed consent.
- Educate study patients concerning informed consent procedures and HIPAA authorization.
- Document study patient's medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines.
- Perform nursing assessments and monitor study patient's progress during clinical trials; track study patient's response by documenting on toxicity flow sheet, medication flow sheet, and nurses' progress notes.
- Maintain accurate, complete, and up-to-date records on each patient participating in a clinical trial protocol in all applicable systems.
- Evaluate and develop study patient education materials and give study patient and/or designated caregiver instructions on drug administration and other medical information.
- Plan for study patient's appropriate care under the direction of a physician or advanced practice nurse.
- Notify 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 sponsor and IRB of record according to established timelines.
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