Assistant Director - Clinical Research Management

About the role

The Assistant Director, Clinical Research Management provides operational leadership and oversight for centralized clinical research management functions supporting investigators and study teams across KU Medical Center and the Health System. Reporting to the Director, Clinical Research Management, the Assistant Director manages the Portfolio Managers team and oversees multisite clinical trial research management operations.

Responsibilities

• Provide operational leadership for centralized clinical research management services.
• Directly manage and develop the Portfolio Managers team.
• Support centralized administration of trial activation, amendment, and closeout processes.
• Identify and support clinical research related vendors and service requests.
• Oversee multisite clinical trial research management operations including financial and contractual workflow development, multisite budget development and site activations.
• Collaborate with the Director on strategic initiatives and operational improvements.
• Develop and monitor operational timelines and performance metrics.
• Serve as an operational resource for investigators, study teams, sponsors, and CROs.
• Ensure compliance with institutional, regulatory, and ethical standards.
• Develop organizational staffing plans and assure that employees with the appropriate education, experience and skills are hired, onboarded, trained, supervised, have individual goals and development plans; receive annual performance evaluations and where necessary implement appropriate employee discipline.
• Ensure area employees conduct activities in a professional and ethical manner, and in accordance with KUMC Policies and applicable local, state and federal laws and regulations.
• Ensure all work performed by employees in the area is done in a safe and secure manner.
• Direct coordination of area work with other areas of KUMC to ensure integration and support of KUMC goals and objectives.
• Maintain personal level of subject matter expertise necessary to ensure the area activities are carried out on a best practices basis.
• Participate in and/or lead appropriate committees, task force, or other similar activities assuring optimal resource utilization.
• Ensure that necessary electronic data collection, storage and retrieval systems are implemented and used by area personnel in an appropriate fashion.
• Ensure that the area maintains any certifications desired by KUMC to further promote quality education and research.
• Ensure the confidentiality of medical center, employee, and patient information. Handle sensitive data with discretion and in accordance with KUMC policies and legal requirements.
• Maintain the highest standards of integrity, respect, professional conduct, and ethical standards.

  Qualifications

  • 5 years of clinical research and/or regulatory affairs experience.
  • 2 years of supervisor experience.
  • Experience with clinical trial study budget development.
  • Experience working in a position that required working knowledge of FDA regulations.
  • Experience working with the MSOffice Suite.
  • Master’s degree in life sciences, healthcare, or related field (preferred).
  • Relevant clinical research certification, such as SOCRA, ACRP, CIP etc.
  • Experience managing multisite clinical trials.
  • Experience with RedCap, myResearch, CRIS/Velos, SmartSheet, Complion systems.

  Benefits

  A comprehensive benefits package is offered, including coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.