Assistant Director - Clinical Research Management

Department:

RI Office of Clinical Trials Administration (OCTA)

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Clinical Research Management Department

Position Title:

Assistant Director - Clinical Research Management

Job Family Group:

Professional Staff

Job Description Summary:

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. This role supports execution of clinical research intake, activation, amendment, and closeout processes, with a focus on operational consistency, compliance, and efficiency across participating sites.

Job Description:

Key Roles and 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.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Required Qualifications

Work Experience:

• 5 years of clinical research and/or regulatory affairs experience. Education can substitute for experience on a year for year basis.

• 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.

Preferred Qualifications

Education:

• Master’s degree in life sciences, healthcare, or related field.

Certifications/Licenses:

• Relevant clinical research certification, such as SOCRA, ACRP, CIP etc.

Work Experience:

• Experience managing multisite clinical trials.

• Experience with RedCap, myResearch, CRIS/Velos, SmartSheet, Complion systems.

Skills

• Leadership

• Communication

• Problem-solving and analytical

• Time management

• Organization

Required Documents

Resume

Cover Letter

Comprehensive Benefits Package:

Employee Type:

Regular

Time Type:

Full time

Rate Type:

Salary

Compensation Statement:

The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above. 

Pay Range:

$80,600.00 - $120,900.00

Minimum

$80,600.00

Midpoint

$100,800.00

Maximum

$120,900.00