Manager-Clinical Research Coordination

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

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/

Please attach a current resume with this application.

General Responsibilities

• To manage all aspects of research program and clinical studies including education/teaching.

• To oversee and manage multiple clinical research protocols and the associated personnel.

• To design best practices for management of IP for drug, device, and biologic studies.

• To prepare study budgets. To manage research staff within area including all applicable human resources functions.

Key Duties & Responsibilities

• Manages all aspects of the research program and clinical studies. Oversees and manages multiple clinical research protocols and the associated personnel.

• Designs best practices for management of IP for drug and biologic studies. Maintains compliance with federal, state, and accrediting agencies (sponsors), including maintaining any required documentation.

• Oversees the use of Electronic Data Capture (EDC) systems and OnCore CTMS, as necessary for operations. Manages the development of standard operating procedures (SOPs) for data quality assurance.

• Manages the development of protocols. Determines solutions for operational shortcomings of data procurement in protocol design. Identifies appropriate stakeholders to ensure adequate design, implementation, and testing of study aims.

• Plans and leads site initiation and closeout visits with sponsors. Employs escalation and performance plans as needed.

• Directs the performance of study audits and monitors activities to ensure compliance with all clinical and regulatory aspects of the research. Manages project organization, including coordination of internal and external regulations and guidelines affecting clinical research.

• Initiates and/or assists with developing and revising policies and procedures for research staff. Trains staff to maintain documentation for all processes.

• Develops protocol-specific systems and documents, including process flows, training manuals, SOPs, and CRFs. Prepares study budgets.

• Provides division-wide training in ethical conduct of research. Assigns, reviews, and trains others in various work responsibilities. Mentors staff, including direct reports. Assists staff in identifying efficiencies and improving processes.

• Manages research staff within the area, including all applicable human resource functions. Develops and employs strategies to maintain recruitment and retention rates.

• Independently conducts literature reviews and contributes to publications and presentations. Leads committees as needed.

• 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

• Demonstrated experience staffing, resourcing, scheduling, and managing clinical study coordinator teams to meet the needs of a diverse portfolio of research studies, including Sponsors', investigators, and patients' needs.

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, 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.