CLINICAL RESEARCH REGULATORY COORDINATOR II

The University of Alabama at Birmingham (UAB), Dermatology, is seeking a Clinical Research Regulatory Coordinator II.

This position works directly with doctors and fellows to complete necessary documentation as it relates to each research study. The position will be required to follow standards set by both the local and central IRB and be able to maintain several ongoing projects with varying deadlines. The ideal candidate should be highly organized and have strong attention to detail. Must be able to communicate well both in person and via email.

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.

Key Duties & Responsibilities

1. Prepares, submits, and assists with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
2. Maintains regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
3. Drafts informed consents.
4. Prepares and maintains FDA applications for INDs and IDEs.
5. Assists in drafting compliant advertisements.
6. Makes and assists in modifying protocols and study documents.
7. Completes and submits safety Reports and government documents as needed.
8. Enters protocol specific data into required institutional systems (IRAP and OnCore).
9. Maintains appropriate licensure for clinicians.
10. Conducts internal quality assurance audits of regulatory files.
11. Oversees maintenance of Delegation of Authority logs.
12. Maintains study's compliance with institutional requirements.
13. Assists colleagues in identifying efficiencies and improving processes.
14. Serves as a mentor to junior regulatory staff.
15. May train others in various work responsibilities and provide constructive feedback.
16. Performs other duties as assigned.

Annual Salary Range : $47,665 - $77,455

Qualifications

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.

Preferences

• The ideal candidate should be highly organized and have strong attention to detail.
• Must be able to communicate well both in person and via email.
• Experience working with an approving or regulatory body would be helpful.
• Experience submitting and preparing documents for review and certification would be helpful.
• The ability to create and maintain systems or processes to track deadlines and multiple projects at once would also be preferred.
• This position works directly with doctors and fellows to complete necessary documentation as it relates to each research study.
• The individual will be required to follow standards set by both the local and central IRB and be able to maintain several ongoing projects with varying deadlines.

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.