From Nancy Burns
Rex Cancer Center Oncology Research Department
Orientation Checklist
Oncology Research Nurse
Name ____________________________
Staff Advisor: Nancy Burns, RN
Date Initiated _____________________
Overall position responsibility: Coordinate clinical trial patient care according to protocol guidelines & Good Clinical Practice.
Collaborate with investigators, nurses, and ancillary staff to ensure patient safety during therapy. Maintain regulatory requirements
according to protocol guidelines. Ensure protocol adherence during active treatment to include oversight of adverse events, dose
modifications, biological specimen collection. Produce excellent clinical data.
A: Good Clinical Practices
1. Applies principles of Good Clinical Practice to all aspects of
work.
2. Applies beneficence, justice and respect for persons to all
aspects of research with human subjects.
B. Confidentiality
1. Understands limits of confidentiality to the subject in all
phases of clinical trial participation.
2. Understands de-identification of records and when this is
necessary.
3. Complies with all aspects related to HIPPA policy
Proficiency:
1. Click on http://phrp.nihtraining.com/users/login.php
2. Complete on-line modules (approx 1.5 hrs)
3. Print your HSPT certificate when finished.
Signature: _______________________ Date:______________
Staff advisor
Proficiency:
1. Click on Department of Health & Human Services site:
“protecting personal health information in research:
understanding the HIPAA privacy rule. Review site:
http://privacyruleandresearch.nih.gov/clin_research.asp
2. Also please view slide presentation:
http://privacyruleandresearch.nih.gov/nih_ppt_priv_rule_an
d_research_01.asp
From Nancy Burns
4. Agrees to protect protocol, data collection, crfs and other
study information from being shared with individuals outside of
the study. Understands that data must be secured in a locked
area.
C. Professional Development
1. Keeps up with current trends in clinical trials industry through
professional affiliation with pertinent organizations such as ONS,
SOCRA, or ACRP. Pursuit of OCN certification is encouraged and
continuing renewal of this or other certifications is expected to
be maintained per organizational guidelines (i.e.: continuing ed
credits, re-taking of accreditation exam)
2. Attendance at conferences such as CALGB, NSABP, or other
organizations which offer learning opportunities is strongly
encouraged.
3. Attendance at regular staff meetings is considered part of the
research nurses realm of practice.
3. Please also review Release of Confidential Information from
the Patients Medical Record. Go to i-POP (policies) on
intranet/cancer center global policies. Please note language re
Clinical Trials participants.
Initials: _____ Date:__________
Signature: ___________________ Date:_____________
Staff advisor
Proficiency:
1. Attend nursing and staff meetings as they occur
Initials: _____ Date: ___________
2. Attend Friday a.m. Tumor board.
Initials: _____ Date: ___________
Establish goals for professional development.
Maintain credentials including nursing license, and any
organizational certifications through continuing education.
Optional: Seek certification by a professional organization
related to clinical trials nursing practice.
Staff advisor’s
Signature: ___________________Date:_____________
D. Patient Care Responsibilities
1. Obtain informed consent for all patients prior to registration
for a trial.
Proficiency:
1. Review consent process & observe informed consent process
with at least 2 new patients. Nursing advisor to witness new hire
in the consenting process (main and HIPAA consents).
Initials: _____ Date: ___________
From Nancy Burns
2. Provide sufficient information to adequately answer all
patient concerns or questions before patient signs an
informed consent.
2. Reviews protocols and study time and events tables, dose
modifications, & can demonstrate.
Initials: _____ Date: ___________
3. Obtains HIPPA consent for all patients enrolled on
any clinical trial.
3. Can successfully demonstrate understanding of eligibility
criteria by review of 3 patients by chart review and interview to
determine their eligibility status.
Initials: _____ Date: ___________
4. Obtains pre-screening consent to be able
to evaluate potential patients for studies as
applicable.
5. Verifies patient eligibility by thorough review of patient
history, records and patient interview.
6. Coordinates all aspects of patient visits including:
 Scheduling all appointments
 labs, radiology, diagnostics and chemotherapy
appointments.
 Writes chemotherapy orders per protocol for Investigator
verification and signature.
7. Provides any educational materials, pill diaries, & visit
calendars to facilitate patient adherence to protocol.
8. Documents all Serious Adverse Events (SAEs), submits a
written report of all SAEs to the Regulatory Specialist for
submission to the IRB. Notifies and/or submits reports to
sponsor as required. Submissions specific time frames are
mandated by the protocol and FDA regulations.
9. Verifies patient eligibility for a trial and submits weekly
4. Reviews and demonstrates proficiency in collecting shadow
chart information and patient scheduling of appointments, labs,
and diagnostics.
Initials: _____ Date: ___________
5. Review SAE process with nursing advisor and demonstrate
understanding of process, timelines and recipients of reports on
the SAE.
Initials: _____ Date: ___________
6. Identify where all patient materials can be accessed.
Initials: _____ Date: ___________
7. Review creation of calendars/patient timelines for 2 different
trials.
Initials: _____ Date: ___________
8. Complete the module on Medwatch at the following site:
http://www.fda.gov/cder/learn/cderlearn/default.htm
Click on FDA Medwatch and patient safety.
Initials: _____ Date: ___________
Demonstrate proficient use of the AdEERS reporting system
From Nancy Burns
listings to the Pharmacy for all patients on the schedule to be
treated in the following week.
10. Provides CRAs with all necessary documentation for each
patient visit, specifically, AE, con med review and drug
accountability information.
Staff advisor’s
Signature: ___________________Date:_____________
during first 6 months after hire date:
https://webapps.ctep.nci.nih.gov/openapps/plsql/gadeers_main
$.startup
9. Review patient visit responsibilities: Demonstrate ability to
write accurate and complete Clinical Research Progress
Notes (CRPNs) including tracking of components of Adverse
Event (AE) documentation – specifically, start/stop dates for
meds and toxicities, investigator’s attribution of each event,
and follow-up of toxicities until resolution. This should
include demonstration of proficiency in using RECIST 1.1
criteria (or Cheson) in the completion of the pt tumor
measurement worksheet, common toxicity criteria, pill
diaries (when applicable) ECOG and Karnofsky ratings for
performance status.
Initials: _____ Date: ___________
10. Successfully submit two Rex Hematology Oncology pharmacy
research weekly logs Initials: _____ Date: ___________
11. Review and demonstrate understanding of how orders are
written for medications, procedures, and labs.
Initials:______ Date:____________
12. Review with CRA, the set-up of one complete shadow chart.
Also, monitor one patient’s chart for 100% source
verification.
Initials: _____ Date: ___________
D. General Responsibilities
1. Protocol coordinators will be available at monitor visits to
answer any questions the monitor may have regarding the
Proficiency:
1. Participates with monitors during site-monitoring visits.
initials: ______ date: ___________
From Nancy Burns
study.
2. Coordinators provide training and orientation to new trials
for clinic staff through start-up meetings and any additional
training sessions which might be necessary.
3. Uses Oncore system to verify trial status, patient information
and other pertinent trial information.
2. Attends multi-disciplinary conferences weekly and identifies
potential trial patients mentioned.
initials: _____ date: ___________
3. Identifies potential staff to coordinate particulars of patient
care on each of 3 trials.
initials: _____date: ___________
4. Oversees arrangements for site initiation meetings.
5. Assures that all study related charges are listed appropriately
on the template, S:/Cancer/Clinical Research
Dept./Oncology Research/Study Related Patient Charges/Rex
Oncology Research Billing.xls
4. Demonstrates proficiency on Oncore after training on the
system with Cathy Watkins. Make an appt to discuss system
with Cathy.
initials: _____ date: ___________
5. Demonstrates understanding and process of billing
procedures for clinical trials patients. Understands the concepts
of conventional care vs. Investigational in relation to billing,
especially nurse responsibilities w contract registrations. See
7. Screen new pts for clinical trial options & provide information Billing Grid developed for each trial.
to investigator prior to first appt, as appropriate. Consider
initials: _____ date: ___________
clinical trial options at LCCC.
6. Assists in completion of 1 cycle of treatment through CRF
8. Save the following websites to your ‘favorites’ & register –
preparation for each of the following types of trials:
password protected sites:
(if applicable)
The Clinical Trials Support Unit (CTSU)
LCCC
Initials: ______ Date: ____________
https://www.ctsu.org/public/
CALGB http://www.calgb.org/
Cooperative
Initials: ______ Date: ____________
6. Interacts with Rex Hematology Onc. Pharmacist to assure
timely and adequate study medication for patients.
NSABP: http://www.nsabp.pitt.edu/
Central IRB http://www.ncicirb.org/CIRB_Login.asp
9. Save the following websites to your ‘favorites’’:
Pharmaceutical
Initials: ______ Date: ____________
7. As the opportunity becomes available, attend one of each of
the following types of meetings related to trial initiation:
From Nancy Burns
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The National Cancer Institute:
http://www.cancer.gov/clinicaltrials/;
The Health & Human Services Office for Human Research
Protection (OHRP)
http://www.hhs.gov/ohrp/assurances/assurances_index.
html;
The Pharmaceutical Management Branch (PMB)
http://ctep.cancer.gov/branches/pmb/
Linberger Comprehensive Cancer Center clinical trials:
http://cancer.med.unc.edu/patient/clinical-trials.asp
The Cancer Therapy Evaluation Program
http://ctep.cancer.gov/
E. Regulatory Responsibilities
1. Assures that no patient goes on trial before all IRB issues are
completely resolved and the trial is approved for enrollment.
2. Protocol coordinators will provide all deviation information to
CRAS for documentation on the protocol deviation log.
3. Protocol exceptions must be well documented by
coordinators for IRB submission with type of exception,
information on party granting the exception, date and
signature of party issuing exception.
4. Review Rex IRB’s Manual on the R drive:
R:doc/final/IRB/Manual/sections I-V.
5. Serious Adverse Events are reported per protocol timelines
Date
Protocol
Pre-site visit
Site initiation
Start-up meeting.
Initials: ______ date:______________
8. Facilitate a Study Start Up Meeting
Initials: ______ date:______________
Signature: ___________________Date:_____________
Staff advisor
Proficiency:
1. Demonstrate knowledge of the IRB process and requirements
for study approvals. Locate critical trial information on the
database system.
Initials: _____ Date: ___________
2. Coordinator will locate deviation log and review with nursing
advisor or preceptor what would constitute a deviation, its
severity and where these should be reported.
Initials: _____ Date: ___________
3. A review of exceptions to protocol, what is acceptable for an
exception and where this information must be submitted will be
reviewed with nursing advisor or preceptor.
Initials: _____Date: __________
4. Discuss Limited Waiver of HIPPA Authorization policy with
Nurse Advisor.
Initials: _____Date: __________
From Nancy Burns
to the appropriate oversight authorities (the Rex IRB,
MEDWATCH, AdEERS system).
6-27-2010/revised 9/10/2012.NB
Staff advisor’s
Signature: _____________________ Date:_______________