CLINICAL RESEARCH REGULATORY COORDINATOR II-(T210873)
The Clinical Research Regulatory Coordinator II will prepare, submit, and assist with multiple levels of clinical research documentation (i.e., IRB submissions, educational materials, reports, grant renewal reports, and study forms) for the Rheumatology Research Unit. The coordinator will maintain regulatory documentation, including consent forms, protocols, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. The coordinator will serve as a resource person or act as a consultant within the area of regulatory expertise.
To prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
To maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
To draft informed consents.
To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
To assist in drafting compliant advertisements.
To serve as resource person or act as consultant within area of regulatory expertise
Prepares and submits IRB applications for the Division of Rheumatology.
Assists in drafting IRB-compliant consents, advertisements, and correspondence.
Makes and assists in modifying protocols and study documents.
Completes and submits safety Reports and government documents as needed.
Enters protocol-specific data into required institutional systems (IRAP, OnCore).
Maintains pertinent records and personnel documentation (e.g., licensure, certifications) for research staff.
Maintain IRB compliance with institutional and departmental requirements for various Division of Rheumatology studies.
Assists colleagues in identifying efficiencies and improving processes.
Performs other duties as assigned.
Annual Salary Range - $47,665 - $77,455
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
Comprehensive understanding of related scientific and clinical terminology
Ability to problem-solve
Clinical Research experience
Knowledge of regulatory/compliance affairs as it pertains to clinical research
:311403000 Med - Immunology/Rheumatology
Work Arrangement (final schedule to be determined by the department/hiring manager):Onsite
In fall 2018, UAB had a third consecutive year of record-high over all enrollment with 21,923 students, including its largest freshman class ever (2,299), with enrollment growth in every school on campus and in the acclaimed UAB Honors College. The freshman class had an average ACT of 25.2 and GPA of 3.73- both higher than 2017. UAB's students are talented and diverse, with minority students making up 40.5 percent of the freshman class and 39.7 percent of the entire of the student body. Logo Logo UAB is was recently recognized as the Top Young University in the U.S. and 10th globally in the Times Higher Education World University Rankings. UAB research expenditures are at a record high, exceeding $562 million in FY17, and UAB ranks 15th in federal funding nationally among public universities (top 4 percent) and 31st overall (top 5 percent). In National Institutes of Health funding, UAB ranks 8th among public universities (top 2 percent) and 23rd overall (top 4 percent) with more than $244 million. UAB Health system has over one million patient visits annually and is home to Alabama's largest hospital and the 3rd largest public hospital in the U.S. UAB houses the state's only level ...1 adult trauma center and the only National Cancer Institute-designated Comprehensive Cancer Center in Alabama and a five-state region. UAB is the state's largest single-site employer, with more than 23,000 employees, and has an annual economic impact of over $7.15 billion on Alabama.