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Full Time

Days

Monday - Friday

8:00a - 4:30p

Minimum 3 years of clinical experience.

Experience in an oncology environment or clinical research experience, preferred.

Job Summary: The Research Quality Monitor (RN) ensures the integrity, accuracy, and compliance of research processes for assigned areas throughout the health system. This role conducts thorough reviews of research methodologies, data collection procedures, and analysis techniques to identify any discrepancies or deviations from established standards.

Minimum Education: Has completed the basic professional curricula of a school of nursing as approved and verified by a state board of nursing, and holds or is entitled to hold a diploma or degree therefrom.

Licensure, Registration and/or Certification: Valid multi-state or State of Oklahoma Registered Nurse License.

Work Experience: Minimum 3 years of clinical experience. Experience in an oncology environment or clinical research experience, preferred.

Knowledge, Skills, and Abilities: Proven knowledge of FDA, IRB, and NIH regulatory requirements. Proficient knowledge of Microsoft 365 and other applicable software. Effective communication skills, both written and verbal that present clear and concise information. Demonstrated ability to organize and prioritize work utilizing strong analytical and time management skills. Ability to work independently and collaboratively in a fast-paced environment, managing multiple priorities with competing deadlines. Sound ability to maintain professional and courteous demeanor and demonstrate flexibility and adaptability in a dynamic work environment.

Essential Functions and Responsibilities: Verifies adherence to protocol specifications for participant recruitment, enrollment, and treatment ensuring accurate documentation and alignment with institutional review boards (IRB), National Institutes of Health (NIH), and the Food and Drug Administration (FDA) requirements. Analyzes documentation and reporting of any deviations from the protocol and assesses the research team’s performance in conducting the study, data collection, and verifying source documents. Reviews protocols in development phase for compliance and efficacy and supervises and reviews the informed consent procedures to guarantee participants’ voluntary and informed involvement. Ensures completeness and accuracy of all informed consent documents and conducts continuous monitoring of participant safety throughout the study. Documents and reports Serious Adverse Events (SAE) and Adverse Events (AE) as mandated. Confirms approval and endorsement of safety plans by study physicians within specified timelines. Maintains up to date knowledge of regulatory obligations related to research studies, standards, and procedures. Prepares for and participates in regulatory inspections and audits, evaluating staff training and qualifications for study-related tasks. Collaborates with the study team to ensure precise and timely data collection and reporting; verifying accuracy of data entered in applicable databases, aligning with study protocol and source documents. Assesses participant records and source documents for accuracy and consistency within electronic study databases. Identifies areas for enhancement and establishes standards in accordance with regulatory requirements and develops and implements policies, procedures, and training sessions to promote best practices. Offers guidance and assistance to study investigators and site personnel.

Decision Making: The carrying out of non-routine procedures under constantly changing conditions, in conformance with general instructions from a supervisor.

Working Relationships: Works with other healthcare professionals and staff.

Special Job Dimensions: None.

Supplemental Information: This document generally describes the essential functions of the job and the physical demands required to perform the job. This compilation of essential functions and physical demands is not all inclusive nor does it prohibit the assignment of additional duties.

Childrens Pediatric Oncology - Yale Campus

Location:

Tulsa, Oklahoma 74136

EOE Protected Veterans/Disability