What are the responsibilities and job description for the CLINICAL RESEARCH REGULATORY COORDINATOR I position at UAB Health System?
The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Regulatory Coordinator l to carry out regulatory duties to support clinical research coordination of studies pertaining to Oncology clinical trials.
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 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 Coordinator l 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
High School diploma or GED required.
Preferences
- Interpersonal skills.
- Knowledge of Microsoft Office products.
- Written and verbal communication skills.
- Knowledge or regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
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.
Primary Location: University
Job Category: Clinical Research
Organization: 310008400 Comprehensive Cancer Center
Employee Status: Regular
Shift: Day/1st Shift
Salary : $19 - $31
