Project Coordinator, DCRI, Clinical Trials Transformation Initiative

Location
North Carolina, United States
Posted
26 Oct 2018
End of advertisement period
26 Dec 2018
Ref
401499592
Contract Type
Permanent
Hours
Full Time

DCRI - CTTI

Job Description

Occupational Summary:

Manage the planning, execution, and follow-up activities of meetings and events of the Clinical Trials Transformation Initiative (CTTI), which are held in Washington, D.C. and other regions outside of North Carolina. Reporting to the CTTI Director of Strategy, implement strategies to streamline communication, financial and other aspects for all CTTI events. CTTI is a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration (FDA) to identify and promote practices to improve the quality and efficiency of clinical trials. CTTI has over 60 members representing national and international organizations such as academia, government, industry (biotech, medical devices, pharmaceutical companies, CROs), investigators, IRBs, patient advocates, and professional societies. Based on results of its projects, CTTI issues recommendations that are used by regulators in developing clinical trial related policies, and by academia, industry and other organizations that design and conduct trials to improve how clinical trials are done.

Work Performed:

Work closely with CTTI’s Communications Manager and leadership to grow and manage CTTI’s thought leadership program, as it relates to conference attendance and visibility. Maintain database of national and international conferences CTTI attends annually. Based on programmatic knowledge of CTTI projects and communication needs, help research new conferences and make recommendations to CTTI Communications Manager and leadership about whether or not CTTI should attend/present. Coordinate communicationswith project teams, meeting organizers and others to ensure CTTI presentations are made at appropriate events. Activities include, but are not limited to, preparing and submitting abstracts and aligning speakers. In consultation with CTTI leadership, communications manager, and project teams/managers, manage logistics for all CTTI events, including expert meetings, where leaders from multiple stakeholders convene to develop recommendations for improving clinical trials and strategies to facilitate their adoption (approximately 4-5 per year) and Executive Committee and Member meetings (2 per year). Other project-related meetings include workshops to educate decision- making about how to implement CTTI recommendations, face-to-face team meetings, and national meetings (approximately 6-8 per year). Meeting attendees include senior faculty from academia, executives from industry, and leaders from government agencies and patient advocacy organizations.

  • Manage the scope, cost, schedule, and quality of each meeting to ensure event objectives are achieved, and there is alignment with CTTI priorities. Create and monitor adherence to timelines and deliverables for assigned meetings.
  • Coordinate all aspects of events. Plan and manage scope, budget, and timeline according to event requirements while maintaining alignment with CTTI overall mission and vision. Prepare reports for CTTI and project leadership.
  • Evaluate, select, and negotiate contracts with providers of services (AV, catering, hotel, transport) according to event requirements. Travel to events and be senior CTTI representative interacting with vendor and service providers.
  • Manage all financial aspects of events, including preparation and monitoring of budgets, and payment of services.
  • Monitor event activities to ensure achievement of meeting objectives, satisfaction of participants, resolution of any problems that arise, and compliance with applicable federal regulations and laws (such as OMB A-21 Circular, conflicts of interest). Ensure appropriate revenue and expense allocations are made to the correct private and federal grant fund codes, as CTTI’s activities are funded by multiple sources.
  • Working closely with the CTTI Communications Manager and Communication Specialist, coordinate communications for meetings. Secure staff to prepare pre-meeting materials and post-meeting deliverables. Monitor the quality of all meeting communications and ensure they are disseminated in concordance with the CTTI overall and project specific communications plans.
  • If applicable, secure sponsors, and coordinate collateral materials to recruit and manage these relationships. If CTTI is co-hosting an event with another organization, negotiate and manage the terms of the arrangement, including co-promotion, within the parameters established by CTTI’s Executive Committee. Develop and implement standard policies, processes, and post-event evaluations to ensure events are conducted in an efficient and cost-effective manner. Keep abreast of meeting management standards and trends and incorporate best practices in the planning and oversight of CTTI meetings. Educate other CTTI staff on best practices. Minimum Hiring Specifications Education/Training: Work requires analytical, communications, and organizational skills generally acquired through completion of bachelor’s degree program. Experience: Work requires a general knowledge normally acquired through one year of related experience. Strongly prefer previous experience planning national off-site meetings and working with multi- sectors (e.g. pharmaceutical, government, patient groups).

Prefer knowledge of clinical trial operations. Experience working in healthcare, clinical research and/or a project-oriented organization preferred. 

HIGHLY PREFERRED ATTRIBUTES include: 

  • Professional demeanor
  • Skill in interacting with senior faculty and executives in industry and government
  • Ability to exercise discretion and judgment
  • Attention to detail
  • Political sensitivity
  • Ability to travel to all events and serve as on-site point of contact

KNOWLEDGE AND SKILLS

  • Budget preparations
  • Event planning Negotiation
  • Strong communication skills (oral, written and listening)
  • Team skills
  • Software knowledge: Microsoft Windows Microsoft Word Microsoft Excel Microsoft PowerPoint

Requisition Number

401499592

Location

Durham

Duke Entity

MEDICAL CENTER

Job Code

1685 PROJECT COORD

Job Family Level

10

Exempt/Non-Exempt

Exempt

Full Time / Part Time

FULL TIME

Regular / Temporary

Regular

Shift

First/Day

Minimum Qualifications

Education

Work requires communication and analytical skills normally acquired through a 4 year college education.

Experience

Work requires a general knowledge of research methods, procedures and activities normally acquired through 1 year of social science research experience.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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.

Auto req ID

105466BR

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