Protocol Specialist I, Comprehensive Cancer Center

Overview

JOB SUMMARY

The Protocol Specialist handles data management activities/tasks for principal investigators and research nurses engaged in clinical trials within the Comprehensive Cancer Center (CCC), which include institutional, cooperative group and industry sponsored trials. This position performs a variety of specialized duties with regard to assigned protocols including extracting and editing data, tracking, coordinating the submission of data internally and externally to the assigned cooperative groups as required, and communicating with staff and faculty members. 

EDUCATION / EXPERIENCE

Minimum Acceptable Qualifications:

1. High school graduation or recognized equivalent
2. Four years of clerical experience, two of which must have encompassed data management duties, or equivalent combination of education and experience
3. Knowledge of medical terminology

Additional Desirable Qualifications:

1. University graduation
2. Experience in the oncology field
3. Knowledge of medical terminology specific to protocols administered

SKILLS / QUALIFICATIONS

• EPIC/WakeOne proficiency to include appropriate documentation of research notes
• OnCore/WISER proficiency
• Basic computer skills required, i.e. Excel, Word
• Excellent organizational skills
• Ability to work effectively with other research personnel
• Good interpersonal and communication skills (verbal, non-verbal, and listening skills) 

LICENSURE / CERTIFICATION / REGISTRATION

• Must complete the CITI certification for Human Subject Research if not already completed
• All additional required WakeOne (EPIC) training for research
• All required WISER (OnCore) training

ESSENTIAL FUNCTIONS

1. Coordinate the entry of new and follow-up patients onto protocols by gathering patient information and entering data into the appropriate institutional and/or Cancer Center clinical research management databases and by submitting the appropriate paperwork to internal and/or external agencies.
2. Extract patient information from medical records charts and other paperwork for submission to coordinating center, including grading of toxicities utilizing standardized protocol charts.
3. Monitor the hospital admissions of patients on the protocols in order to gather and report data in a timely manner.
4. If applicable, edit patient information which has been extracted by ancillary institutions.      Provide timeliness reports, quality control feedback, corrections, and necessary training to ancillary institutions.
5. Monitor the compliance with protocols by maintaining a detailed knowledge of each protocol administered.
6. Communicate with others, including but not limited to Protocol Specialists, departments, physicians, nurses, and institutions, regarding the patients on the protocols.
7. Maintain a summary of the status of each research protocol by ensuring that all required data is entered into the database in a timely fashion.
8. Contact patients and/or family members regarding the patient's status according to the established time frame.
9. Participate in and/or conduct audits with regards to the assigned protocols.
10. Maintain an organized and accurate filing system.
11. Attend relevant investigational and professional meetings and keep abreast of current developments in the field.       
12. Perform other related duties incidental to the work described herein.