- BSN degree***(updated, must be a BSN, RN + BS is not
acceptable with hiring standards)
Must have (one or the other):
- Clinical Research Experience
- Oncology Certified Nurse (OCN)
--- 2-5 years!
- must have NJ RN license
Job Summary and Responsibilities: 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.
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
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
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,
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
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
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
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
Working Conditions: Lifts a minimum of 5 lbs., pushes and pulls
a minimum of 5 lbs. and stands a minimum of 6 hours a day.
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:
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