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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.

Assists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potential.

Assures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.

Acts as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol.

Interacts with regulatory specialists and principal investigators and sub-investigators on all regulatory issues and changes within the protocol.

In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.

Reviews study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.

Recruits and evaluates potential study patients, and works with clinical research coordinator to schedule required appointments and interviews.

Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (i.e., age, culture, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).

Reviews medical records for potential study patients and ensures 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.

Instructs 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.

Assists investigator with consent process assuring study patients understand clinical trials and obtains written informed consent.

Educates study patients concerning informed consent procedures, HIPAA authorization.

Documents study patient¿s medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines.

Performs nursing assessments and monitors study patient's progress during clinical trials; Tracks study patient¿s response by documenting on toxicity flow sheet, medication flow sheet and nurses¿ progress notes.

Maintains accurate, complete, up-to-date records on each patient participating in a clinical trial protocol in all applicable systems (i.e. electronic medical record, clinical trial management system, departmental and protocol specific databases).

Evaluates and develops study patient education materials and gives study patient and/or designated caregiver instructions on drug administration and other medical information; creates study specific calendars for study patients.

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.