Clinical Research Regulatory Specialist II

UAB Medicine; University (FL); On-site; USD 47,665 - 77,455; Full time

Job summary

UAB Medicine in Florida is seeking a Clinical Research Regulatory Coordinator II to manage research documentation and ensure compliance. The ideal candidate will have a Bachelor's degree in a relevant field and at least three years of related experience.

This position entails preparing FDA applications, maintaining regulatory documents, and mentoring junior staff. Strong communication and organizational skills are essential, as well as familiarity with OnCore and RedCap systems.

The annual salary range for this position is $47,665 - $77,455.

Qualifications

• Bachelor's degree and three years of related experience required.
• Strong understanding of clinical trial operations and regulatory processes.

Responsibilities

• Prepare and submit multiple levels of research documentation.
• Maintain regulatory documentation including consent forms and protocols.
• Draft informed consents and prepare FDA applications.
• Conduct internal quality assurance audits of regulatory files.
• Train and mentor junior regulatory staff.

Skills

Communication skills

Organizational skills

Leadership skills

Education

Bachelor's degree in a related field

Tools

OnCore

RedCap

Job description

UAB Medicine in Florida is seeking a Clinical Research Regulatory Coordinator II to manage research documentation and ensure compliance. The ideal candidate will have a Bachelor's degree in a relevant field and at least three years of related experience.

This position entails preparing FDA applications, maintaining regulatory documents, and mentoring junior staff. Strong communication and organizational skills are essential, as well as familiarity with OnCore and RedCap systems.

The annual salary range for this position is $47,665 - $77,455.