Cancer Center Jobs

Executive Director, Clinical Research Services

Sylvester Comprehensive Cancer Center, University of Miami Health System

October 27, 2021
The Sylvester Comprehensive Cancer Center has an exciting opportunity for a Executive Director, Clinical Research to work on the UHealth Campus. The Executive Director, Clinical Research reports to the Assistant Vice President of Research Administration and indirectly reports to the Associate Director for Clinical Research and the CRS Medical Director to oversee all aspects of CRS functions. This position is responsible for directing the design, development, activation, and execution of all cancer related clinical studies. The Executive Director, Clinical Research provides central administrative functions across all Clinical Research Service (CRS) divisions including, but not limited to Regulatory and Protocol Development Office, Research Committees, Clinical Trials Coordinating Unit, and the CRS Training and Education Office. The role of the ED is to ensure all divisions operate optimally to meet the NCI criteria for the Clinical Protocol and Data Management and the Protocol Review and Monitoring System functions. 

Works closely with SCCC leadership to develop long and short-range strategic plan for the area of Clinical Research at SCCC

Works closely with CRS Medical Director (s) to oversee all aspects of CRS functions and provides administrative oversight, leadership direction and support to all team members in the conduct and support of clinical trials at SCCC main campus.

Analyze financial structures at SCCC main campus to help maximize income and existing resources and minimize expenses.

Works with CRS leadership on the development and maintenance of CRS SOPs.  Designs and implements necessary systems, processes and procedures for the support of clinical research to be used across CRS Main campus. This includes overseeing the creation and maintenance of policies and procedures as they relate to good clinical practice, regulatory affairs, quality assurance, and control systems.

Supervises the protocol compliance and patient safety of research activities at main campus involving protocol review and activation, screening, data management, study coordination and regulatory oversight.

Responsible for the quality improvement, updating and implementation of complex data management systems to code all SCCC patient research data; prepares complex and comprehensive reports for investigators and/or sponsors; evaluates research findings.

Through direct reports maintains complete oversight of the day-to-day operations of all CRS divisions including regulatory affairs

Collaborates with scientific and clinical faculty, managers, sponsor representatives, other departments, vendors, regulatory agencies and staff in problem solving, conflict resolution, and study audits.

Directs the development, implementation, and maintenance of CRS standard operating procedures, training and user manuals.

Responsible for the quality improvement, updating and implementation of complex data management systems to code all patient research data; prepares complex and comprehensive reports for investigators and/or sponsors; evaluates research findings.

Responsible for accurate and timely completion and maintenance of NCI-required Data Tables and other clinically related statistics, including but not limited to gender and minority statistics.

Consults with and advises Investigators and CRS staff on relevant regulatory issues, using knowledge of federal, state and other levels of policies and procedures and Good Clinical Practice.  Keeps current with agency and regulatory rules and advises Senior Leadership appropriately.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS 

Bachelor’s degree in relevant field required

Masters degree in healthcare or business-related field preferred.

Minimum 15 years of relevant experience required (Minimum of 10 yrs of progressively responsible work experience in the conduct and management of cancer clinical trials and Minimum of 5 years experience and demonstrated record of effectiveness in a management/supervisory related position preferred)

Clinical research certification (CCRP, CCRA or CCRC) preferred.

Oncology experience preferred

Experience conducting quality assurance reviews and data analysis preferred.

Comprehensive understanding of Good Clinical Practice guidelines, Code of Federal Regulations relating to clinical research, clinical trials monitoring and regulatory compliance. 

The ability to take initiative and provide research faculty and staff with quality support and a high degree of accuracy.

Demonstrates creativity, innovation, flexibility and willing to accept challenges.

Demonstrates a willingness to devote whatever effort is necessary to achieve team success.

Exceptional interpersonal skills are required and excellent verbal and written English communication skills are necessary to deal effectively with individuals both inside and outside the organization from diverse backgrounds.

Ability to manage multiple priorities and organize and prioritize work to meet deadlines.

Any appropriate combination of relevant education, experience and/or certifications may be considered.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

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