Clinical Research Coord, RN
Company: Hackensack Meridian Health
Posted on: February 13, 2020
SunIRef:GP Clinical Research Coord, RN Hackensack Meridian
Health 337 reviews - Hackensack, NJ 07601 Hackensack Meridian
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Description: The Clinical Research Coordinator, RN is responsible
for coordinating and overseeing clinical operations of a clinical
trial and participates in assessing, planning, implementing and
evaluating patient care in clinical research studies. The Clinical
Research Coordinator, RN carries out the research and works under
the general supervision of the principal investigator responsible
for the clinical trials. Responsibilties: 1. 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. 2. Assures that all protocol revisions,
informed consents, continuing reviews, serious adverse events are
submitted to the appropriate IRB of record in a timely manner. 3.
Acts as liaison between principal investigators and
sub-investigators on all regulatory issues and changes within the
protocol. 4. In collaboration with the principal investigator,
reviews studies for feasibility and evaluates potential competition
with other protocols prior to submitting study. 5. Reviews study
with principal investigator to a budget outlining standard of care
and research costs. Finalizes budget draft with budget coordinator.
6. Recruits and evaluates study patients, schedule appointments and
interviews. 7. 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.). 8. 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. 9. 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. 10. Assists investigator with consent process assuring
study patients understand clinical trials and obtains written
informed consent. 11. Educates study patients concerning informed
consent procedures, HIPAA authorization. 12. Documents study
patient's medical history including but not limited to past
medical/surgical treatments, significant medical conditions, and
medication history per protocol guidelines. 13. 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. 14.
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. 15. Plans for study
patient's appropriate care under the direction of a physician or
advanced practice nurse. 16. Notifies principal investigator of any
adverse events and serious adverse events, including evidence of
drug toxicity or unexpected side effects. 17. Reports all serious
adverse events to sponsor and IRB of record according to
established timelines. 18. Coordinates research activities not
limited to: scheduling laboratory tests, radiology testing and
other medical exams. 19. 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. 20. Act as principal investigator's
representative as appropriate. This may include communicating with
sponsors and their representatives, the IRB and other medical
personnel. 21. Maintains accurate, complete, up-to-date records on
each patient participating in a clinical trial protocol. 22.
Ensures study patient's clinical trial related activities are
billed appropriately and reconciles drug study account records with
research finance personnel. 23. Prepares and assists for sponsor
monitor site visits and ensures all supporting documentation
records are adequate and available for the visit; Meets with
monitor at least once during each monitor site visit and resolves
all issues found during visit. 24. Develops case report forms
and/or databases for physician initiated studies as needed. 25.
Assists the principal investigator in preparing for publication.
Works with analysts and assists with queries related to data to
evaluate the significance of collected data. 26. Provides education
to all departments and clinical areas where study is performed. 27.
Attends research meetings and conferences as required. 28.
Participates in staff meetings and in-service education of nursing
and medical staff. 29. Adheres to the standards identified in the
Medical Center's Organizational Competencies. Qualifications:
Education, Knowledge, Skills and Abilities Required: 1. Graduate of
a NLN/AACN accredited program in nursing. 2. 3-5 years clinical
nursing experience. 3. Adheres to the American Nurses Association
standards. 4. Mandatory education on human subjects research.
Education, Knowledge, Skills and Abilities Preferred: 1. BSN
preferred. 2. FDA regulatory, IND reporting, Microsoft or similar
Office Suite, oncology or clinical research. Licenses and
Certifications Required: 1. NJ State Professional Registered Nurse
License. Licenses and Certifications Preferred: Hackensack Meridian
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Keywords: Hackensack Meridian Health, Hackensack , Clinical Research Coord, RN, Healthcare , Hackensack, New Jersey
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