CLINICAL RESEARCH REGULATORY COORDINATOR III
University of Alabama at Birmingham
Description
The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator III.
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 prepare and submit multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
To prepares and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
To lead the implementation of study specific regulatory processes of a moderate to complex nature.
To conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations.
To design and implement quality initiatives ensuring effective and efficient clinical processes.
Key Duties & Responsibilities
Prepares and submits multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms). Prepares and maintains FDA applications for INDs and IDEs. Leads the implementation of study specific regulatory processes of a moderate to complex nature.
Conducts internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations. Designs and implements quality initiatives, ensuring effective and efficient clinical processes.
Writes reports, business correspondence, and procedure manuals. Plans, develops and presents training. Develops and oversees the implementation of Standard Operating Procedures (SOPs) when needed. Improves processes as needed.
Serves as a mentor to junior regulatory staff. Trains others in various work responsibilities and provides constructive feedback. Serves as liaison with medical staff, University Departments, ancillary departments, satellite facilities, IRB and sponsor contacts.
Plans, develops and present training. Ensures research staff completes all requisite training.
Serves on various committees as appropriate. Stays active in relevant regional and national forums.
Performs other duties as assigned.
Annual Salary Range: $55,180 - $89,670
Qualifications
Bachelor's degree in a related field and five (5) 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 preferred.
Preferences
Knowledge of ICH-GCP guidelines.
Accuracy, thoroughness, and attention to detail.
Skilled in maintaining/reviewing records.
Skilled in developing and maintaining effective working relationships with staff.
Ability to work independently, train and mentor staff as well as within a team.
Ability to communicate effectively with peers, physicians, and management both orally and in written form.
Must be self-directed/self-motivated.
Skill in time management and executing workload with minimal supervision.
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.