PROGRAM COORD - Duke Cancer Institute

Employer
Duke University
Location
Research Infrastucture & Administration

Job Details

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

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.

Organization

Read our Diversity Profile History

Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.Duke Campus

As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.

Duke maintains a historic affiliation with the United Methodist Church.

Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.

Mission Statement

Duke Science"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'

“To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.Duke Meeting

 “By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert