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Occupational Summary

Coordinate the daily activities Safety Oversight Committee [SOC] and Monitoring Team for the Duke Cancer Institute’s [DCI] Protocol Review Office [PRO] in compliance with Duke Policies and the National Cancer Institute’s [NCI] requirements for the Cancer Center Support Grant [CCSG]. Use knowledge and skills to independently resolve complex administrative problems.

Work Performed

Program Management

Independently manage the monitoring portfolio and coordinate monitoring visits with the disease group teams.

Assess study status and accruals to identify protocols requiring monitoring and safety oversight using relevant databases. Ensure all subjects signing consent are registered in appropriate systems. System examples are eIRB, eResearch, iRIS, OnCore, and Epic. Review study files, paper and electronic CRFs, and data collection tools for accuracy, legibility and consistency. Verify data entries with source.

Prepare for monitoring visits. Review protocol and research documents. Review electronic databases for regulatory and toxicity documentation and subject registration. Prepare appropriate monitoring documents. Provide feedback and education to study teams to facilitate successful protocol management.

Maintain the DCI Monitoring calendars.

Contribute to the ongoing development and improvement of forms, tools, templates and processes.

Manage, coordinate and administratively lead SOC meetings. Initiate, when indicated, an ad hoc meeting.

Coordinate SOC and DCI Monitoring Committee orientation and training for new members as well as the Oncology Clinical Research Units’ [OncCRU] clinical research staff.

Follow standard operating procedures [SOPs]. Optimize SOPs to collect clinical trial data in a cooperative and validated manner; monitor data quality with respect to accuracy, consistency, reliability, and reconciliation with other data sources; take corrective actions when needed to protect data integrity.

Collaborate with leadership to develop and execute processes. Evaluate program performance, summarize findings, communicate results, and form action plans.

Attend department and Institutional Review Board [IRB] meetings, as assigned and required.

Coordinate and complete special projects independently and in cooperation with other groups as assigned.

In collaboration with leadership, generate complex and detailed presentations and reports for DCI meetings and events.

Coordinate annual strategic planning meetings for compliance and clinical research office, including preparation of meeting materials, tracking needs assessments and following up on action items to ensure deadlines are met.

Communication

Coordinate communications within the organization on behalf of SOC and PRO leadership.

Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Refer complex questions and escalate issues to others as appropriate.

Ethics

Know and follow policies, standard operating procedures (SOPs), regulations and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.

Other work as assigned.

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Minimum Qualifications

Education

Work requires analytical, communications and organizational skills generally acquired through completion of a bachelor's degree program.

Experience

Work requires one year of experience in program administration or involving academic, instructional or counseling activities to acquire skills necessary to plan, coordinate and implement a variety of program activities and events. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.