Clinical Trials Regulatory Specialist — Remote/Hybrid

University of Alabama at Birmingham; Birmingham (AL); Hybrid; USD 48,000 - 77,000; Full time

Job summary

The University of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, seeks a Clinical Research Regulatory Coordinator II to prepare, submit, and assist with various levels of regulatory documentation for IRB submissions to UAB, WIRB, Advarra, and others. The role maintains regulatory materials including ICFs, protocols, 1572s, CVs, licenses, and recruitment tools, and drafts informed consents.

It also prepares FDA applications for INDs and IDEs and serves as a regulatory resource within

Qualifications

• Bachelor's degree in a related field required.
• Three (3) years of related experience required.
• Experience with regulatory documentation and IRB submissions.

Responsibilities

• Prepare, submit, and assist with multiple levels of research documentation (IRB submissions, educational materials, reports).
• Maintain regulatory documentation including consent forms, protocols, CVs, licenses, and recruitment materials.
• Draft informed consents and FDA applications for INDs and IDEs; assist with advertising compliance.

Skills

Regulatory knowledge

IRB submissions

FDA paperwork

Education

Bachelor's degree

Job description

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Regulatory Coordinator II.

The Clinical Research Regulatory Coordinator II will prepare, submit, and assist with multiple levels of research documentation, IRB submissions to UAB, WIRB, Advarra, and others. Maintain regulatory documentation, including ICF, protocol, 1572, CVs, ML, IB, recruitment materials, submission forms, and draft informed consents. Maintain/prepare FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). To serve as a resource person or act as a consultant within the area of regulatory expertise.

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, 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.
• 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.

Preferences

• Advanced knowledge in regulatory matters related to clinical trials and retrospective IRBs.
• Basic knowledge of clinicaltrials.gov, consenting, protocol review, adverse and serious adverse event reporting.
• Ability to work independently, to make decisions, to interact with sponsors, regulatory authorities, and investigators.
• Ability to communicate effectively with physicians, sponsors, and other collaborators.
  
  

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.

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