MANAGER-CLINICAL RESEARCH REGULATIONS

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Manager-Clinical Research Regulations.

The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. On campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care. The link to our website is: https://www.uab.edu/onealcancercenter/

The position will ensure oversight and management of the O'Neal Cancer Center Regulatory Team; manage the preparation and submission of multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms) for the O'Neal clinical trials activities. Core responsibilities include leading the implementation of study specific regulatory processes and maintaining study compliance with institutional and sponsor requirements. This role will supervise 15 clinical research regulatory coordinators.

Please attach a current resume with this application.

General Responsibilities

• To oversee regulatory team in larger organizations.
• To manage the preparation and submission of multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• To lead the implementation of study specific regulatory processes of a moderate to complex nature.
• To maintain study s compliance with institutional requirements.
• To serve on various committees as appropriate.
• Performs other duties as assigned.
  
  

Annual Salary Range: $77,640 - $126,170

Bachelor's degree in a related field and eight (8) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification strongly preferred.

Preferences

• Critical thinking skills.
• Problem-solving skills across a wide variety of clinical studies.
• Expert knowledge of related scientific and clinical terminology.
• Leadership skills.
• Negotiation skills.
• Presentation skills.
• Prioritization skills.
• Organizational skills.
• Process improvement and quality skills.
• Written and verbal communication skills.
• IRB regulatory experience.
• FDA knowledge.
  
  

UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, religion, sexual orientation, gender identity, gender expression, and veteran’s status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB’s Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.

Primary Location

University

Job Category

Clinical Research

Organization

310008400 Comprehensive Cancer Center

Employee Status

Regular

Shift

Day/1st Shift

Work Arrangement (final schedule to be determined by the department/hiring manager)

Remote/Hybrid Eligible