Yale Cancer Center Clinical Trial Office

Yale Cancer Center Clinical Trial Office

Clinical Research Nurse I/II Competencies and Measurement Criteria

Employee Name:

Date of Hire:

Orientation Period:

Preceptor/Mentor Name:

Competency
(CTO Key Accountability & Goal crosswalk) / Learning Option
  Classroom
  Web Based
  Preceptor
  Clinical Trial Office Staff
  SOP
  Case Review
  Literature Review
  Professional/Educational Meeting attendance / CRN I/ II Measurement Criteria
The Oncology Clinical Research Nurse will demonstrate the ability to:
Protocol Management & Compliance
(CTO Terminology: Conduct of Research) / To be determined /   Identify the requirements of clinical trials, including objectives, sample sizes, and patient care needs based upon the phase of the trial.
o  Phase I
o  Phase II
o  Phase III
o  Phase IV
  Identify sources for, and facilitate adherence to, current regulations, guidance, and policies that affect research at the institutional, state, federal, and international levels.
o  Institutional
o  State
o  Federal
o  International
  Promote compliance with the processes and procedures required by different types of sponsors
o  Investigator-Initiated
o  Industry
o  National Cancer Institute Cancer Therapy Evaluation Program
  Protect patient, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
o  HIPPA
o  Adheres to SOP for PHI
  Participate in discussions regarding feasibility of protocol implementation based on knowledge of institutional capabilities and limitations, therapy, patient population, or care site..
o  Uses the Feasibility Checklist to prepare for meeting
o  Contributes to protocol feasibility determination at meetings.
  Collaborate with the research team to implement procedures for maintaining patient study participation from enrollment through completion
o  Enrollment
o  On Treatment Visit
o  End of Study visit
o  Follow Up
  Identify the HIC/IRB of record, protocol-related policies of the IRB, and preferred contact method.
o  Participates in providing timely, informative, and accurate communication to the HIC as required.
  Participate in the preparation for and implementation of meetings with external and internal monitors and auditors
o  Quality Assurance
o  HIC
o  FDA
o  Sponsor Monitors
o  Medicare reviewers
  Ensure validity of research results by
o  Documenting timely, accurate, and complete data in
§  EPIC
·  Consent
·  Screening
·  Eligibility Determination
o  SOP 2 RN Review
·  Enrollment/Registration/Randomization
·  On Treatment Visit
o  Toxicity Assessment
o  Concomitant Medication List Review
o  Laboratory Result Review
o  EKG Result Review
o  Patient Education
o  Physician Investigator, Research Pharmacist, CRSL,& Infusion Nurse Communications
o  Oral study medication verification
·  Dose modifications
·  SAE Submission
·  End of treatment visit
·  Follow up visits
§  OnCore
·  Attend OnCore Training- Subject Maintenance
·  Eligibility determination
·  SAE submission
·  Deviations
·  Death
o  Prepare and submit serious adverse event reports
§  Adeers (https://webapps.ctep.nci.nih.gov/openapps/plsql/gadeers_main$.startup)
§  Industry Sponsor
§  IIT
  Collaborate with principal investigator, research pharmacist, and other appropriate personnel to ensure proper use of and accountability for:
o  Oral study medications
o  Infusion study medications
o  Injectable study medications
o  Experimental devices (optional)
Clinical Trials Related Communication
(Communication & Participation within Disease Team) /   Ensure ongoing formal and informal communication regarding clinical trials with team members by
o  Participating in weekly Disease Team Meetings
o  Participating in weekly Tumor Board Meetings
o  Participating in Site Initiation/Protocol Kick off Meetings
  Provide general clinical research as well as trial-specific information to research, clinical, and other organizational staff by:
o  Preparing slides and providing Clinical Nurse/Infusion Nurse/In-patient Nurse Protocol Inservice prior to FPFV.
o  Providing re-training as needed or upon request.
  Develop collaborative relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials by:
Describing the roles and responsibilities of clinical research staff:
§  Principle Investigator
§  Co-investigators
§  Project Manager
§  Data Manager
§  Regulatory Assistant
§  Research Assistant
§  Clinical Trial Assistant
§  Unit Clinical and Administrative Staff
§  Research Pharmacist
§  CRSL personnel
§  Diagnostic Radiology
o  Shadow key CTO staff (PM, DM, CTA, CRSL, Research Pharmacy)
  Provide education related to clinical trials to patients and their significant others including:
o  Rationale for trial
o  Study related procedures and tests
o  Study medication MOA, usage (dose, route, frequency, special considerations such as fasting) side effects, and management of side effects
o  Study calendar-treatment schedule, test schedule (labs, scans, EKG, etc.)
o  Disease Team contact information
  Advocate for clinical trials by participating in community outreach efforts to provide general clinical trial education (optional)
  Advocate for the safety and care of clinical trial patients
  Advocate for the promotion and integrity of the clinical trial.
Informed Consent Process
(CTO Terminology-Conduct of Research) /   Ensure the initial and ongoing consent process is performed and documented in compliance with FDA, International Conference on Harmonization Good Clinical Practice (GCP), institutional, sponsor, IRB, and other applicable regulations, guidance, and policies.
o  Reviews SOP SM Obtaining Informed Consent
o  Orientee observes 3 informed consents (at least one with the physician investigator)
o  Orientee assists/conducts 3 informed consents
o  Orientee provides evidence of appropriate documentation in the clinical research nurse informed consent progress note
  Participate in the education of clinical trial patients about :
o  clinical trial
o  significant new information that is forthcoming during or after the conduct of the trial requiring re-consent
  Assesse for barriers to effective informed consent discussions and implements plans to overcome them.
o  SOP Non-English speaking
§  Short form
§  Interpreters
o  SOP Vulnerable Populations
Management of Clinical Trial Patients
(Conduct of Research) /   Facilitate New Protocol Template Build in Beacon by:
o  Reviewing protocol after PRC/Feasibility and creating draft worksheets and Protocol Template “Quick Sheet” for Beacon Administrator
o  Meeting with CRSL to verify that lab template is correctly incorporated into the Quick Sheet
o  Reviewing draft template and providing timely feedback, in collaboration with the PI and Research Pharmacist, to the Beacon Administrator.
  Collaborate with the investigator to ascertain study patient eligibility, including documentation of criteria specified in the protocol.
o  Uses Protocol Playbook to guide development of Eligibility Checklist
o  SOP 2 RN review
  Ensure adherence to the protocol schedule of events and other requirements in collaboration with the clinical research team.
  Ensure scheduling of all procedures required to assess for adverse events and disease response to the study intervention in collaboration with the clinical research team.
  Ensure the successful acquisition/completion of correlative components of the clinical trial:
o  Research laboratory acquisition
o  QOL questionnaires
o  EKGs
§  Demonstrates the ability to perform EKG with the protocol specified technology/equipment
  Assess patients for trial-related and non–trial-related symptoms and
  In collaboration with the clinical and clinical research staff, ensure evidence-based symptom management while maintaining trial compliance.
  In collaboration with the treating physician investigator and/or APP investigator, assist with the completion of the toxicity assessment.
  Report these findings per the protocol and FDA, sponsor, and HIC policies, if appropriate.
  Utilize adverse event assessment data and clinical judgment to determine if a dose-limiting toxicity has occurred or if any treatment schedule or drug dose modifications are necessary and communicates findings to the clinical research team and sponsors.
  During phase I/dose escalation studies, collaborate with the principal investigator to determine when the maximum tolerated dose has been achieved based on adverse event assessment data and clinical judgment.
o  Evaluates disease response results and physical assessment data in conjunction with the principal investigator to determine response per the protocol.
  Support and evaluate patient adherence to the protocol by utilizing various methods to assist with documentation, patient education, and oral study medication return.
  Identify vulnerable patients who require increased nursing assessment and management in addition to the clinical trial requirements.
Documentation
(Conduct of Research) /   Comply with regulations, institutional policies, and sponsor requirements governing source data and documentation.
  Document assessment, management, and evaluation in source documents for patients on clinical trials as appropriate to the protocol and role.
o  Smilow Chart documents
o  EPIC EMR
o  OnCore
  In collaboration with the PM and DM, educate research and clinical team members regarding appropriate and accurate source documentation for participants in clinical trials.
  In collaboration with the DM, ensure that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.
  Follow the SOP for making corrections to data entry in clinical records and case report forms, if necessary.
  Ensure that all regulatory documents are processed and maintained per YCC, HIC/IRB, and GCP regulations.
  Demonstrate proficiency in the use of clinical and research-related computer programs including
o  OnCore
§  Subject Maintenance Training
o  EPIC
§  Ambulatory Oncology CS 100 & 200
Patient Recruitment
(Conduct of Research) /   Smilow Cancer Hospital Care Center
o  Assist in implementation of recruitment plans to identify and assess individuals who might be eligible for clinical trials, taking into consideration the study entry criteria, required procedures, and other potential factors.
o  Identifies and develops processes to overcome barriers to recruitment related to patient demographic factors, underserved populations, and healthcare system influences.
o  Identifies institutional or community-based resources or groups that can assist in achieving recruitment goals.
o  In collaboration with the treating physician investigator, periodically prescreen patients for protocol eligibility
Ethical Issues
(Conduct of Research) /   Demonstrate an understanding of the protection of human subjects.
  Advocate for ethical care of clinical trial patients and the conduct of clinical trials in accordance with standards of oncology nursing practice.
  Promote ongoing compliance with key ethical concepts by the clinical research team including
o  informed consent,
o  documentation,
o  respect for persons,
o  beneficence, and
o  justice
  Identify and ensure that members of vulnerable populations enrolled in clinical trials are identified and that their rights are addressed.
  Identify and follow YCC institutional procedures to report any falsification of data or scientific misconduct.
Financial Implications
(Conduct of Research) /   Describe the key components included in study budgets
  Confer with the principal investigator or finance personnel when protocol revisions will affect the costs of protocol management.
  Identify routine care (SOC) versus research-related costs, the financial impact on patients, and the need for financial counseling.
  Optional-Ensure and track submission of specified items (e.g., completed case report forms, specimens) to facilitate timely recovery of protocol-related activity costs
  Optional-Ensures that stipends to patients for protocol-related activities are disclosed to the IRB during approval of the consent form.
Professional Development /   Participate in educational opportunities to increase knowledge about clinical trials, regulations and guidance, and the role of the CTN.
  Seek resources on an ongoing basis that provide oncology treatment and nursing practice updates, such as through professional mentoring and meetings, journals, and Web sites.
  Identify and complete within the appropriate timeframe yearly FOCUS goals.
  Obtain specialty certification.

Employee Signature Date

Preceptor/Mentor Signature Date

Supervisor Signature Date

Comments:

Areas for Development & Additional Goals