Atlantic Research Group is looking to hire a Clinical Research Nurse to join our growing team. This position is located in Hackensack, NJ. Do you enjoy the thought of playing a major role on the clinical trial management side of an exciting therapeutic study? If so, this opportunity may be for you.
The Clinical Research Nurse is responsible for coordinating and overseeing clinical operations of a clinical trial and participates in assessing, planning, implementing and evaluating Compliant Patient Care in clinical research studies. The Clinical Research Nurse carries out the research and works under the general supervision of the principal investigator responsible for the clinical trials. The below list of duties (listed in order of importance) will give you a view of your day-to-day responsibilities.
- Assures that all protocol revisions, informed consents, serious adverse events are submitted to the appropriate IRB of record and/or Sponsor according to established timelines.
- Interacts with regulatory specialists and principal investigators and sub-investigators on all regulatory issues and changes within the protocol
- 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
- 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
- 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, potential drug administration and other medical information;creates study specific calendars for study patients.
- 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 nurses’ progress notes and source data worksheets. 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.
- Performs and/or oversees a variety of clinical duties that may include but not limited to: EKGs, processing/shipping of blood serum, urine and communicates results to PI and/or APN.
- Prepares and assists for sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor during each site visit and resolves issues found during visit.
Knowledge, Education and Skills:
- Graduate of a NLN/AACN accredited program in nursing required
- 3-5 years clinical nursing experience required
- Mandatory education on human subjects research
- BSN preferred
Required Certification/Licensing:
- Current valid NJ State Professional Registered Nurse license.
ARG is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. ARG also complies with all work authorization and employment eligibility verification requirements and is an E-Verify employer.