Position Summary

The primary responsibility of the research nurse is to manage all aspects of conducting clinical trials. The research nurse is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the research nurse will act as liaison between the investigators, primary care providers, the institutional review board (IRB), and the sponsor. Along with the investigator, the research nurse will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the nurse is responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensures sound conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, and followup of eligible subjects according to protocol requirements (e.g., subject followup, case report form completion, and reporting of adverse drug experiences).
• Maintains accurate and complete documentation, including but not limited to regulatory documents, signed informed consent forms, relevant IRB approvals, source documentation, drug dispensing logs, subject logs, and study-related communications.
• Organizes all aspects of the trial, including but not limited to timeliness in completing case report forms (CRFs), data entry, reporting adverse drug experiences (ADEs), managing caseload and managing study files.
• Maintains communication of all protocol-related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial, concerns regarding possible ADEs or subject compliance.
• Demonstrates professional conduct in the presence of subjects, research staff, sponsors, monitors, etc.
• Develops and maintains enrollment/follow-up mechanisms
  1. Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility.
  2. Review with the principal investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol.
  3. Review the protocol summary sheet and the informed consent form for accuracy and clarity.
  4. Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity.
  5. Develops mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.
  6. Prepare IRB applications and ongoing amendments, as directed.
  7. Screening and enrollment procedures
  8. Review and verify all relevant source documentation in the subject’s medical record to confirm study eligibility.
  9. Review the protocol, informed consent form, and follow-up procedures with potential study subjects.
  10. Ensure the current approved informed consent is signed before subjects are screened and enrolled.
  11. Ensure that the randomization procedure is followed as per protocol guidelines.
  12. Document protocol exemptions and deviations, as appropriate.
  13. Ensure adherence to protocol requirements.
  14. Schedule subjects for follow-up visits.
  15. Assess subject response to therapy and evaluate for adverse events.
  16. Review laboratory data and communicate abnormal values to the primary care provider and investigator.
  17. Assess and document subject compliance with medications and visits.
  18. Communicate with pharmacy staff to assure timely and accurate study drug distribution.
  19. Administer study drug therapy as needed and maintain the study drug dispensing log if the pharmacy is not involved in the study (as legally appropriate).
  20. Maintain copies of all prescriptions written for study drug supplies, as appropriate.
  21. Ensure appropriate specimen collection.
  22. Attend study-related meetings as appropriate.
  23. Communicate regularly with the principal investigator about study-related issues.

• Case report form (CRF) preparation and study documentation

1. Ensure timely and accurate CRF completion for each study subject.
2. Key data for remote data entry or provide completed CRFs on a timely basis.
3. Maintain source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports.
4. Provide auditors with completed CRFs, medical records, lab data and other source documents for review.
5. Correct and edit CRFs, as appropriate.  

• Adverse experience monitoring and reporting responsibilities

1. Assess and record all ADEs as outlined in protocol.
2. Report all serious ADEs to the principal investigator, sponsor’s monitor, primary care physician, and IRB as outlined in the protocol.

• Regulatory documentation

1. Maintain copies of all required regulatory documents.
2. Prepare IRB submissions, protocol revisions, and renewals as needed, and maintain copies of all  
3. IRB communications.

• Sponsor and/or FDA audits

1. Ensure that all required documentation is complete and appropriately filed.
2. Provide all required documentation to auditors.
3. Make all appropriate corrections as requested by auditors.

• Study close-out

1. Ensure that all study documentation (regulatory, IRB communications, patient and drug logs, etc.)        
2.                        is appropriately filed.
3. Ensure that all CRFs are complete and that all forms have been forwarded to the sponsor or    
4.                        entered into the computer, as appropriate.
5. Store all files in a permanent and safe location.
6. Notify the IRB of the study’s completion, according to IRB procedure.

• Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).
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1. Education

• RN required

• BSN preferred

• Oncology certification (OCN) or oncology experience preferredB.      Qualifications/Experience

• Experience working within the oncology field preferred.

• Clinical research-related experience preferred

• Experience organizing multiple tasks, working with diverse groups of people.

• Ability to work independently and self-direct work activities.

• Detailed oriented and able to meet established deadlines. C.      Special Skills/Knowledge

Demonstrates computer literacy with basic knowledge of MS Office programs.

• Successfully complete in-hospital orientation and competencies.

• Demonstrates comfort in making presentations to and facilitating small to medium-sized groups (i.e. business, professionals, community agencies, etc.).

• Possesses excellent communication and interpersonal skills to establish a high degree of rapport and professional interaction.

• Maintains strict confidentiality at all times.

• Ability to build positive working relationships with physicians and external agencies.

• Ability to communicate with multiple levels of organizations and community (managers, physicians, clinical, and support staff).

• Possesses a broad and varied knowledge base that is continually enhanced and updated through self-directed study and participation in educational opportunities, with experience/emphasis in adult, geriatric and/or oncology care desired.