Clinical Research Nurse
3 weeks ago
We are seeking a highly skilled Clinical Research Nurse to join our team at Hackensack Meridian Health. As a Clinical Research Nurse, you will play a critical role in ensuring the success of our clinical trials by providing exceptional patient care and ensuring compliance with regulatory requirements.
Key Responsibilities- Assure that all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate IRB in a timely manner.
- Interact with regulatory specialists and principal investigators on all 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 prior to submitting the study.
- Review the study with the principal investigator and/or clinical research coordinator to create a budget outlining standard of care and research costs.
- Recruit and evaluate potential study patients, and work with the 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.
- Communicate with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).
- 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, following guidelines set forth by the protocol sponsors.
- 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 care, available trials, treatments, and side effects.
- Assist the investigator with the consent process, assuring study patients understand clinical trials and obtain written informed consent.
- Current and valid New Jersey Nursing license is required.
- 3 years of clinical nursing experience or 1 year of clinical nursing experience with 2 years of clinical research experience is required.
- Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC) is preferred.
- Education on human subject research and GCP (CITI Training and Certification) is preferred.
- Knowledge of clinical trials and the regulation (local, state, and federal) of such is preferred.
- Familiarity with basic scientific and healthcare principles and terminology preferred.
- BSN preferred.
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