Job Description

Overview The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator I. The Clinical Research Regulatory Coordinator I will carry out regulatory duties to support clinical research coordination of studies pertaining to Oncology clinical trials. A comprehensive designation means UAB Medicine patients have access to leading-edge treatments or clinical trials. On campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse and 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. Website: Please attach a current resume with this application. General Responsibilities To assist in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. To assist with preparation of Institutional Review Board (IRB) submissions including preparing all relevant documentation and obtaining necessary signatures to meet study timelines. To assist with initial drafts of informed consent documents. To prepare regulatory binders and associated documentation. Key Duties & Responsibilities Under supervision, the Clinical Research Regulatory Coordinator I will be responsible for the following: Assists in maintaining regulatory documentation, including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. Assists with preparation of Institutional Review Board (IRB) submissions, including preparing all relevant documentation and obtaining necessary signatures to meet study timelines. Assists with initial drafts of informed consent documents. Prepares regulatory binders and associated documentation. Enters protocol-specific data into required institutional systems (IRAP and OnCore). Maintains Delegation of Authority logs. Performs other duties as assigned. Hourly Range: $18.85 - $30.65 Qualifications High School diploma or GED required. Preferences Interpersonal skills. Knowledge of Microsoft Office products. Written and verbal communication skills. Knowledge of regulatory documentation, including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. Details 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 Equal Opportunity Statement: 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. #J-18808-Ljbffr UAB Medicine

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