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ASSOCIATE DIRECTOR RC&E, DCRI

Duke Clinical Research Institute
United States, North Carolina, Durham
300 West Morgan Street (Show on map)
Dec 09, 2024

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Position Summary

The Associate Director of Research Communications & Engagement (RC&E) is responsible for leading, managing, and directing the efforts of a designated team of research communicators and managers in order to ensure effective planning, oversight, and coordination of communication project deliverables, ranging from protocols and clinical study reports to participant recruitment materials and program websites. The Associate Director is responsible for monitoring the progress and performance of all communication projects within his/her remit to ensure the quality of services provided, timeliness of deliverables, compliance with regulatory requirements (where applicable), and adherence to financial targets. He/she facilitates the training and career development of all direct reports, determines project requirements, sets communication strategy, and matches direct reports to tasks and project teams based on background, expertise, interest, and availability.

** NOTE:This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC.

Primary Responsibilities and Tasks

Financial Management



  • Determine project resource requirements from RC&E functional subgroups (medical editing, medical writing, study & project engagement) and shared services (graphic design, production, digital) to ensure efficient use of resources and budget. Prepare budgetary forecasts and ensure systems are regularly updated with forecasting requirements and resourcing assignments.
  • Negotiate RC&E budgets and contracts with independent contractors and vendors. Monitor expenditure of funds relative to scope/budget on an ongoing basis. Ensure that variances are identified and mitigated.
  • Escalate the under or over utilization of budget to the primary project leader to effectively monitor financial performance of research projects.
  • Identify operational problems, issues, obstacles, and barriers across RC&E projects based on input from direct reports, project leaders, faculty, project team members, and sponsors; communicate patterns and trends to the Director of RC&E as appropriate; and participate in and support efforts to develop and implement process/system improvements.
  • Oversee efforts of direct reports to develop communication deliverables on time, on budget, and to a high degree of quality. Monitor progress of all deliverables on an ongoing basis relative to established timelines and key milestones. Ensure that delays are identified and communicated to project leaders, faculty, and functional group leadership in a timely manner. Participate in and facilitate efforts to implement appropriate interventions in order to meet timelines.
  • Work with project leader and faculty to identify resources required for each study and ensure appropriate assignment/availability of RC&E staff.
  • Lead the business justification process to support hiring in line with business needs.



Business Development



  • Improve the RC&E team's approach to business development to facilitate the award of new work and sustain the business.
  • Support organic growth within key projects and sponsors.
  • Represent functional group in sales presentations and other business interactions with sponsors.
  • Provide input into marketing and sales materials (slide presentations, brochures, etc.) regarding the capabilities and services of RC&E and how the group integrates with the rest of the DCRI to deliver value to sponsors.
  • Develop the research strategy and budgets for bids and proposals supporting RC&E.



Process Improvement & Regulatory Compliance



  • Champion the development of new ways to improve and innovate service delivery (process improvement, new technology/approach).
  • Use and innovate upon standard processes and tools to improve the quality of clinical research communications.
  • Develop and implement templates and processes to support team tasks and deliverables.
  • Play an active role in the development and delivery of training/tools to promote best practices in clinical research communications.
  • Serve as a Subject Matter Expert for SOP development for operational activities that are subject to regulatory requirements.
  • Represent the functional group in audits as required, including internal compliance audits, sponsor audits, and audits conducted by regulatory authorities. Review audit reports, provide input for audit responses prepared by the Quality Assurance group, and assist with developing corrective and preventative action plans. Provide support to ensure that action plans are fully implemented in a timely manner.



Personnel Management



  • Manage and direct the efforts of direct reports and recommend personnel actions including but not limited to performance management, scheduling and work assignments, disciplinary action, promotions, and transfers. Define and communicate job descriptions and performance standards and expectations.
  • Lead the interview, hiring, and onboarding process for cross-functional team members.
  • Support the coordination of regular staff meetings and communication of departmental and organizational activities, goals, and policies.
  • Develop and implement orientation programs for new employees as well as ongoing training, continuing education, and professional development.
  • Establish accurate and consistent productivity expectations and revise as needed.
  • Make recommendations regarding staffing requirements to meet departmental needs and achieve maximum productivity.



Other Duties

Performs other related duties incidental to the work described herein.

Required Qualifications

Education/Training:



  • Bachelor's degree required.



Preferred degree in life sciences, communications, public health, clinical research or related field. Master's degree preferred.

Experience:(refer to the Duke HR website for minimum qualifications required if applicable)



  • Nine years of relevant experience to include 4 years in leadership roles.



Experience in the clinical research, health care, or medical products industries (public or private); regulatory agencies; health care-related foundations; patient advocacy organizations; professional societies; or academic institutions preferred; or the equivalent combination of education and experience.

Knowledge, Skills and Abilities:



  • Exceptional oral and written communication skills.
  • Experience preparing and delivering presentations for sponsors and industry/professional forums.
  • Experience in industry and/or government-sponsored clinical research.
  • Proven leadership and management skills with the ability to take initiative and lead with a sense of urgency and inspire both direct reports and peers.
  • Strong skills in planning, prioritization, delegation and organizational development.
  • Collegial, collaborative, and diplomatic interpersonal style and ability to implement inclusive approaches to foster consensus and engagement across diverse stakeholders and constituents.



Minimum Qualifications

Education

Bachelor's degree required

Experience

Nine years of relevant experience to include 4 years in leadership roles. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Minimum Qualifications

Education

Bachelor 's degree required

Experience

Nine yea rs of relevant experience to include 4 years in leadership roles. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE



Education

Bachelor's degree required

Nine years of relevant experience to include 4 years in OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE leadership roles.



  • Bachelor's degree required.


    • Nine years of relevant experience to include 4years in leadership roles.


    • Ex ceptional oral and written communication skills.
    • Experience preparing and delivering presentations for sponsors and indus try/professional forums.
    • Experience in industry and/or gove rnment-sponsored clinical research.
    • Proven leadership and m anagement skills with the ability to take initiative and lead with a sense of urgency and inspire both direct reports and peers.
    • St rong skills in planning, prioritization, delegation and organizatio nal development.
    • Collegial, collaborative, and diploma tic interpersonal style and ability to implement inclusive approach es to foster consensus and engagement across diverse stakeholders a nd constituents.




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.


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