Description

General Responsibilities

• To prepare and submit multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

• To prepares and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).

• To lead the implementation of study specific regulatory processes of a moderate to complex nature.

• To conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations.

• To design and implement quality initiatives ensuring effective and efficient clinical processes.

Key Duties & Responsibilities

1. At an advanced/complex level will, prepare and submit research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

2. Prepares and maintains FDA applications for INDs IDEs.

3. Leads the implementation of study-specific regulatory processes.

4. Conducts internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations.

5. Designs and implements quality initiatives ensuring effective and efficient clinical processes.

6. Develops and oversees the implementation of Standard Operating Procedures (SOPs) when needed, improves processes as needed, and writes reports, business correspondence, and procedure manuals.

7. If appropriate will plan, develop, and present trainings.

8. Serves as a lead for other CRRC I and CRRC II through mentoring, training, and oversite.

9. Makes sure that other research staff has all requisite training.

10. Maintains appropriate licensure for clinicians.

11. Liaison with medical staff, internal/external departments such as IRB sponsors, etc.

12. Performs other duties as assigned.

Annual Salary Range: $55,180 - $89,670

Qualifications

Preferences

• Preferred candidates will have experience with UAB Clinical Research.

• This position will require advanced knowledge of Clinical Research Regulations.

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.

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