Associate Director, Clinical Trials Office and Business Operations - Military Veterans

at Duke University and Duke University Health System

Durham, North Carolina

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

Occupational Summary

Under the direction of the Director, Research Strategy and Operations (DRSO), this position is responsible to provide leadership in Duke Cancer Institute’s (DCI) clinical research and clinical trials business enterprise as an administrative agent of the DCI.  Components of the leadership include strategic planning, operations, fiscal and managerial administration of clinical research operations, clinical research support and human resources of the DCI’s Oncology Clinical Research Unit (CRU) and support services.  This includes but not limited to the supervision for the required National Cancer Institute (NCI) committees, data, all reporting requirements, safety and data monitoring, internal and external audits.  In concert with the Director and Deputy Director of Clinical Research, this position is the clinical research administrative leader for the DCI.  This position reports to Director, Research Strategy and Operations and will work closely and collaboratively with the DCI Cancer Services to administer an integrated research and clinical oncology program at all DCI clinical sites.

 

Principal Duties and Responsibilities

This position, will develop and sustain the DCI’s clinical research enterprise business management, project workload and financial projections, to ensure best practices and stewardship of DCI’s resources.

In collaboration with the Associate Director of Research Finance and financial managers, develops short- and long-term budgetary projections for resources and services of research programs, groups and services.  This position identifies and obtains new research revenues, including overseeing development of multi-project, multi-investigator grants, such as Program Project Grants (PPGs), Specialized Programs of Research Excellence grants (SPOREs) and other large mechanisms, such as U54 contracts. 

The Associate Director of DCI Research and Clinical Trials Business Operations works with the other Senior Leaders to develop and implement research goals and scientific priorities, working to ensure appropriate allocation of resources. 

This position will have the final approval of budgets, contracts and requests of DCI’s clinical research enterprise.

This position is a key team partner in the production of DCI’s strategic plan and assists in the preparation annual budget for clinical research programs.  This includes the 5-year DCI strategic plan, general fund allocation, endowments, gift accounts, alteration/renovation, start up and various Principal Investigator (PI) accounts recharge facilities, and contracts.

 

Leadership Functions 

Responsible for establishing, developing, implementing and coordinating research programs and laboratories (Cancer Center Research Lab and Cancer Center Clinical labs).   This position will facilitate DCI research, electronic capture, invoicing and other grant related space allocation and the charge-back mechanism, budget, and continuing evaluation of the clinical research throughout DCI. 

In conjunction with the DCI’s DRSO, Associate Vice President of Cancer Services, Assistant Vice President of Nursing and Deputy Director, this position will assist with the implementation of DCI strategic planning initiatives as around multi-disciplinary research within the clinical oncology programs.

This position will attend the Senior Leadership meetings and in the absence of the Director will facilitate the meeting.  Assists with implementation of policy and strategy for the DCI Senior Leadership in the areas of clinical research facilities and operations, research and clinical committee and support operations, finances and human resources. 

This position is, in concert with the Director and the Cancer Center Support Grant (CCSG) manager, responsible for the External Advisory Committee (national leaders who evaluate scientific progress at least annually), the Basic Science Leadership Committee (basic science program leaders and members at large), and the Senior Leadership initiatives to ensure integration of scientific priorities and allocation of resources within the DCI.

When the DRSO is absent this position will represent the DCI within Duke Medicine by attending the Management Council and Business Manager groups other senior Duke Medicine committees.

This position may represent the DCI at external meetings, such as the Cancer Center Administrators’ Forum, Society for Research Administrators, etc.  This position participates and works to ensure coordination and synergy with other large institutional efforts, such as the Clinical and Translational Science Award (CTSA), Brain Tumor Center, etc.  This position works collaboratively with the Human Research Protections Office (eIRB), Office of Regulatory Affairs and Quality (ORAQ), the Duke Office for Clinical Research (DOCR), and the offices of the Associate Dean for Clinical Research and the Assistant Dean for Research Administration.

The Associate Director of DCI Research and Clinical Trials Business Operations prepares and presents periodic and special reports on DCI research-related activities.

 

Operations 

The Associate Director of DCI Research and Clinical Trials Business Operations will oversee the day-to-day operations and financial stability of the clinical research NCI grant related components of the DCI, and collaborates with the various other basic, clinical and translational groups.  This position facilitates collection of all data essential for ongoing DCI monitoring and reporting.  This includes collection of data for financial stewardship, grants, contracts, publications, collaborations, research development funds, shared resource use, membership.

This position oversees the team of staff regarding disease groups and research programs for DCI grant, contract, and gift activities in grant and contract resources.  This includes responsibility for annual progress reports.  This position provides strategic administrative support to DCI members in the development and submission of inter/intra-programmatic grant applications to foster DCI translational research outcomes.  This includes a special focus on Cancer Prevention and Control multi-project, multi-investigator grants, such as Program Project Grants (PPGs), Specialized Programs of Research Excellence grants (SPOREs) and other large mechanisms, such as U54 contracts.

This position, with the DRSO, oversees the related electronic data systems.

 

Human Resources 

This position works to develop strategies for staff development and retention, as well as structuring or restructuring of positions as appropriate.  This position develops and implements training and orientation programs for new staff.

 

Supervision 

Directly supervises assigned staff with broader responsibility for all CRU staff positions.

Lead, supervise and manage staff including coaching, time-off, annual performance review, performance management, career development, training, hiring and termination. 

Model the DCI’s core value “Cancer Care as It Should Be” for staff.  Create a team culture that fosters open communication, motivates staff, and encourages creativity.  Seek out, listen to, accept and act on feedback.  Establish regular communication methods and meetings with staff; collectively and individually.  Be available to staff on a routine basis to provide leadership and mentoring. 

Provide staff with clear measureable goals, monitor performance and quality of work.    Assign staff duties and responsibilities; cross-train and reassign as needed to effectively conduct clinical research.  Foster and encourage the professional development of staff.  Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research.   

 

Skills

  • A significant interest in multi-disciplinary research, training and clinical missions of Duke Cancer Institute. With an authentic aspiration to support those missions through providing of a first-rate administrative and business services.
  • Executive level project, strategic planning expertise, academic medicine and advanced financial skills. 
  • Strong track record in promoting novel and expansive clinical and scientific funding and operation paradigms.
  • A successful record of accomplishment of leadership in a complex matrix managed environment.
  • Outstanding interpersonal and political skills with proven evidence of working effectively both internally and externally with a wide variety of constituents.
  • Political skills essential for a complex matrix environment with additional external institutional relationships.
  • A thorough understanding of the different components required in a clinical and research operation.
  • Demonstrated experience pulling together a high-performing administrative and/or research team and developing the skills and ideas of staff and faculty.
  • A history of managing the operations of a complex environment with a history of creating and successful implementation of operating procedures.
  • Strong familiarity with funding agencies and all aspects of academic grant – contact management including accurate reporting of data and compliance with requirements of government agencies, industry and private donors.
  • Successful in driving cultural change that engages and aligns individuals and teams across the organization. 
  • Proven ability to achieve organizational integration, assimilate efficiencies, motivate teams, introduce and implement new concepts and methods.
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The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.  

 

    Minimum Qualifications

     

    Education

    Bachelor degree in a scientific, allied health or related field of study. Master degree preferred.

     

    Experience

     

    Minimum of seven years of experience with management of research staff, experience with grant proposals and budget development, experience with REDCap software implementation and data management skills.At least one year of experience in proven leadership and effective management of the work of a large staff. General knowledge of internal and external research compliance regulations. Skills: The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job- related tasks other than those specifically presented in this description. Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individuals 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 communityfeel 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.

     

     

    Preferences

    The preferred candidate will have

    • 7 years of experience in clinical research, research and financial management, grant development or strategic planning function.
    • A minimum of 5 years of supervisory experience
    • Experience in academic research administration and operations 
    • A Master degree

     

    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.

     

    Durham, North Carolina

    As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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