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Associate Director of Compliance and Training.

Job description


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Associate Director of Compliance and Training.
DCI OFFICE OF RESEARCH SUPPORT

Occupational Summary
The Duke Cancer Institute's [DCI] Associate Director [AD] of Compliance and Training facilitates processes for faculty and staff to grow and expand their clinical investigation and clinical trial portfolio; responsible for the entire DCI training and education program and ensures a broad integration of programs and services. Compliance/QA and training is critical to DCI's strengths and activities and goals; coordinate these activities with the DCI's programmatic efforts.

The AD is responsible for the administrative and operational needs and interests of the NCI required committees. This includes the Cancer Protocol Committee (CPC), the Safety Monitoring Committee (SOC) and the DCI's Clinical Research Unit [CRU] Education Program, which includes interventional and non-interventional clinical trials, correlative research and the translation of discovery from bench to patients and community as part of an NCI-designated Comprehensive Cancer Center. In partnership with Duke IRB, these committees have scientific and safety oversight for all oncology trials, both interventional and non-interventional at Duke University and Duke University Health System.

The AD will supervises a large and diverse team of staff who carry out clinical trials, tissue acquisition, and biospecimen collections for a variety of research programs, services, resources, and clinical research functions of the community sites of the DCI. The AD will provide expert management of the operational and budgetary needs and oversee clinical research operations at community sites, data quality, regulatory compliance, quality assurance and safety, the integration of high quality standards into clinical operations and scientific review.
Develop collaborative opportunities and effective relationships with sponsors, university partners, hospital affiliates, investigators and regulatory agencies.

Develop strong collaboration with all relevant groups (Trial Sponsors, Trial Project Leaders, Administrative Operations, Cores/Components, Research Practice Managers [RPMs], Assistant Research Practice Mangers [ARPMs], Finance Research Managers [FRMs], and performance sites) to develop and manage clinical project timelines.

Coordination and Integration of Education and Training Activities

The AD is the senior management to develop, implement and sustain training and education opportunities for students, trainees, health professionals and junior faculty to enhance their education and training.
With support staff, ensure the Cancer Center Support Grant [CCSG] Office of Cancer Research Career Development coordinates activities with the DCI's programmatic efforts and leverages the Clinical and Translational Science Award [CTSA] training efforts.

The AD outreaches to and engages these programs by DCI leadership and membership through DCI member provided lectures, seminars and work-shops offered. Tracking and monitoring the success of the OCRCD and the trainees will be of key importance to measure the goal of these approaches to identify trainees with an invested interest in cancer research, and providing these trainees with cancer specific educational and training opportunities across this spectrum to increase engagement in cancer research.

Supervision

Direct reports - approximately 5 to 6 with 15-20 indirect reports
And other work as assigned

Requisition Number
401526157

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1058 DIR, RESEARCH DEVELOPMENT

Job Family Level
94

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University 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 essential job 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.

Education

Bachelor's degree in English, communications, science, business or a related field. Advanced degree is highly desirable with demonstration of an understanding and familiarity with a broad range of science or technical subject matter.

Experience

Seven years of experience working with extramural grants and contracts. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

The preferred candidate will have:
• 10 plus years of progressive leadership in research administration in an academic or non-profit environment
• A proven track record in a successful academic research organization and in a complex business and compliance environment, familiarity with federal agency accounting policies and regulations, business and leadership savvy and the ability to collaborate in a responsible, values-driven, high-quality and cost-effective way also required.
• Must have exceptional analytical, leadership and communication abilities.
• The ability to understand technical research protocols and successfully lead within the research environment is paramount.
• Knowledge of organizational policies, standard operating procedures, and systems.
• Knowledge of regulatory requirements for clinical research.
• Strategic planning skills.

Skills
  • Oversee the regulatory team and foster a collaborative environment
  • Work closely with our research sites and internal teams
  • Provide leadership and collaboration across DCI and Duke School of Medicine to enhance our training and education program from staff, students, trainees and junior faculty
  • Assesses organizational processes associated with startup and support to identify ways to improve and streamline processes
  • Be a strong team member including writing and editing of the CCSG grant
  • Problem solves with the managers and other leadership as they arise
  • Assists in developing and executing the DCI internal and external strategies
  • Provides oversight, leadership, and direction in the study startup of trials and in maintenance areas where support is provided
  • Keeps executive and management team abreast of issues, progress, and risks related to support operations
  • Develops, implements, and evaluates programs to promote recruitment, retention, and continuing education of the team
  • Attends and participates in all required meetings including weekly operational review and Director's meeting
  • Assists in development and tracking of department goals and metrics
  • Works closely with monitors, sponsors/CROs, sites, and team to ensure quality and timely work being delivered
  • Tracks and communicates to team and sites performance expectations and status
  • Works with other members in Clinical Research Operations to ensure communication and responsibility are effective and appropriate


Auto req ID

107603BR

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

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.

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Job No:
Posted: 12/5/2018
Application Due: 2/3/2019
Work Type:
Salary: