CLINICAL RESEARCH REGULATORY COORDINATOR III

University of Alabama at Birmingham; Birmingham (AL); On-site; USD 55,000 - 90,000; Full time

Job summary

The University of Alabama at Birmingham seeks a Clinical Research Regulatory Coordinator III to manage SAE reports, CAPA, deviations, and regulatory submissions. You will prepare IRB materials, maintain FDA documentation, and support study teams to ensure compliance.

Bachelor's degree in a related field and five years of related experience are required; CCRC/CCRP preferred. Onsite in Birmingham, AL with Day Shift.

Qualifications

• Bachelor's degree in a related field and five years of related experience.
• CCRC or CCRP certification preferred.
• Experience with IRB submissions and regulatory documents.

Responsibilities

• Direct responsibility for SAE, CAPA, and deviations.
• Prepare regulatory documents and IRB materials.
• Maintain FDA applications for INDs/IDEs.
• Lead regulatory processes for studies.
• Mentor junior regulatory staff.

Skills

Writing skills

ICH-GCP knowledge

IRB/FDA knowledge

Leadership

Problem-solving

Presentation skills

Prioritization

Organizational skills

Process improvement

Verbal communication

Teamwork

Education

Bachelor's degree in related field

Tools

FDA knowledge

Job description

The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center, is seeking a Clinical Research Regulatory Coordinator III. This position is responsible for preparing, writing, reporting, and following up on Serious Adverse Events (SAE), CAPA, and deviations.

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/

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

Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.

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.

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

• Direct responsibility for preparing, writing, reporting, and following up on Serious Adverse Events (SAE), CAPA, and deviations.


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


• Prepares and maintains FDA applications for INDs and IDEs.


• Leads the implementation of study-specific regulatory processes of a moderate to complex nature.


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


• Designs and implements quality initiatives, ensuring effective and efficient clinical processes. Writes reports, business correspondence, and procedure manuals.


• Plans, develops, and presents training.


• Develops and oversees the implementation of Standard Operating Procedures (SOPs) when needed.


• Improves processes as needed.


• Serves as a mentor to junior regulatory staff.


• Trains others in various work responsibilities and provides constructive feedback.


• Serves as liaison with medical staff, University Departments, ancillary departments, satellite facilities, IRB, and sponsor contacts.


• Plans, develops, and presents training.


• Ensures research staff complete all requisite training.


• Maintains appropriate licensure for clinicians.


• Serves on various committees as appropriate.


• Stays active in relevant regional and national forums.


• Performs other duties as assigned.

Preferences

• Prefer a health, science, or business administration degree.


• Strong writing skills, preparation of regulatory documents.


• Knowledge of ICH-GCP guidelines.


• IRB regulatory experience, FDA knowledge.


• Critical thinking skills.


• Problem-solving skills across a wide variety of clinical studies.


• Expert knowledge of related scientific and clinical terminology.


• Leadership skills.


• Ability to work independently as well as within a team.


• Negotiation skills.


• Presentation skills.


• Prioritization skills.


• Organizational skills.


• Process improvement and quality skills.


• Strong verbal communication skills.

Organization

310008400 Comprehensive Cancer Center

Employee Status

Regular

Shift

Day/1st Shift

Work Arrangement (final schedule to be determined by the department/hiring manager)

Onsite