MANAGER-CLINICAL RESEARCH COORDINATION

The University of Alabama at Birmingham (UAB), Med - Cardiovascular Disease is seeking a Manager-Clinical Research Coordination. This position will support the DOM Cardiovascular Disease Clinical Trials Unit.

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 research program and clinical studies, including education/teaching. Oversees and manages multiple clinical research protocols and the associated personnel. Provides human resource oversight for subordinate personnel.

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.

Plans and leads site initiation and closeout visits with sponsors. Employs escalation and performance plans as needed. Conducts internal quality assurance audits.

Manages protocol-specific data into required institutional systems (IRAP, OnCore, etc.) 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. Writes reports, business correspondence, and procedure manuals as needed.

Provides division-wide training in ethical conduct of research. Assigns, reviews, and trains others in various work responsibilities. Mentors staff including direct reports, graduate students, and postdocs. 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.

Acts as a subject matter expert (SME) for faculty and staff regarding administrative duties for industry and sponsored clinical research.

Manages, assesses, and determines solutions for operational shortcomings of protocols.

Manages and determines operational elements needed for the conduct of clinical studies.

Manages and assists colleagues in identifying efficiencies and improving processes. Serves as a mentor to junior staff. Assigns, reviews, and trains others in various work responsibilities. Establishes and assigns the activities of subordinate personnel to accomplish study goals. Participates in relevant regional and national forums.

Performs other duties as assigned.

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

Qualifications

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.

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.