Associate Director Clinical Operations

Location
California, United States
Posted
Friday, 29 January 2021
End of advertisement period
Monday, 29 March 2021
Ref
88271
Contract Type
Permanent
Hours
Full Time

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine.  The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University.  We seek an Associate Director, Clinical Research Operations to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach.  Given the SCI’s mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth.  The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting.  You will be working with an unparalleled leading edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.   

Reporting to the Director, Clinical Research Operations, the Associate Director (AD), Clinical Research Operations, will lead teams of Clinical Research Managers conducting cancer clinical research in the Cancer Clinical Trials Office.  The AD will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to lead impactful clinical research programs with a focus on high quality and efficiency.  We are seeking candidates with excellent organizational skills, attention to details and willingness to learn.  Candidates must be eager to take on challenges with a high degree of professionalism, initiative and flexibility.  Responsibilities include working with Clinical Research Managers, clinical research staff and Stanford Health Care departments.

Duties include:

  • Contribute to strategy and direction to establish objectives for the overall operation for a clinical trials organization.  Lead implementation of strategy for organization.
  • Determine staffing levels, select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
  • Identify, clarify, and resolve issues with strategic impact and substantial significance, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge requiring broad discretion and judgment.
  • Implement and maintain quality control standards, and evaluate program effectiveness.
  • Negotiate with internal departments and external agencies (FDA, NIH, Hospitals) with authority to commit resources and effort.
  • Collaborate with Hospital and SoM leadership on the direction of clinical research and operational objectives.  Develop strategies to ensure effective achievement of objectives (both short and long term).
  • Serve as a liaison to external organizations/agencies.  Negotiate and establish external resource contracts.
  • Participate in the evaluation and submission of grant applications in support of clinical research infrastructure and operations for multiple trials.
  • Monitor affiliated sites to ensure faculty, administration, and staff meet educational and regulatory requirements for participation in clinical research.
  • Manage operational budget, assign resources within budget constraints, secure resources for new initiatives, report on financial health of operations.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

  • Master’s in Business, Management, Nursing, Public Health or related field
  • Senior level management skills with experience developing strategies and leading the administrative and financial operations of a large organization to implement tactical programs in support of the strategies, preferably in a National Cancer Institute-designated cancer center, other large academic clinical research program such as a CTSA, hospital unit, or in an industry-based clinical research organization.
  • Proficiency in Microsoft Office and database applications.
  • Excellent written, verbal, interpersonal, and presentation skills. Ability to communicate effectively with scientific, medical, professional, executives, administrative, and other personnel at all levels of an organization.  Ability to build relationships and enable effective communications.
  • Experience with research protocols and regulatory or governing bodies, which include HIPAA, and FDA regulations, Institutional Review Board requirements and Good Clinical Practices.
  • Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.  Additionally, the Associate Director should be familiar with insurance billing, and the Medicare Coverage Act.  

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree plus eight years of relevant experience or combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Demonstrated experience leading and managing staff and/or managers.
  • Demonstrated experience leading multi-site or large-scale clinical trials research.
  • Management experience with developing strategies and leading the administrative and financial operations of a large organization academic or industry-based clinical research organization.
  • Demonstrated ability to interact and influence internal senior leadership and external stakeholders.
  • Demonstrated leadership, planning and change management skills.
  • Strong knowledge of industry standards and/or regulatory requirements.
  • Demonstrated expertise in project management, analytical problem solving, and negotiating experience.
  • Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
  • Demonstrated analytic and critical thinking skills, writing skills, communication skills and consulting skills.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification preferred.

PHYSICAL REQUIREMENTS*:

  • Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
  • Occasionally stand, use a telephone or write by hand.
  • Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

  • Occasional local and overnight travel.

WORK STANDARDS:

  • Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
  • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
  • Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.

Additional Information

  • Schedule: Full-time
  • Job Code: 4617
  • Employee Status: Regular
  • Grade: H
  • Requisition ID: 88271
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