Clinical Research Operations Lead & Compliance Manager

UAB Medicine; University (FL); Vor Ort; USD 78.000 - 126.000; Vollzeit

Zusammenfassung

The University of Alabama at Birmingham (UAB) Family & Community Medicine Chair Office is seeking a Manager-Clinical Research Administration. This role oversees all clinical trial operations, manages coordinators, ensures regulatory compliance, and collaborates with internal and external sites to drive efficient trial execution.

Ideal candidates bring strong leadership, organizational, and communication skills with a proven track record in clinical research management.

Qualifikationen

• Bachelor's degree in a related field with 8+ years of related experience.
• Work experience may NOT substitute for education requirement.
• CCRC or CCRP certification strongly preferred.

Aufgaben

• Act as SME for administrative duties for industry and sponsored clinical research.
• Serve as a referral resource for the clinical research community at UAB.
• Manage study compliance with institutional requirements.
• Oversee division-wide training in ethical conduct of research.
• Assess and resolve operational shortcomings of protocols.
• Provide HR oversight for subordinate personnel.
• Supervise clinical research coordinators and staff across multiple trials.
• Prepare and maintain regulatory documentation, including IRB submissions and amendments.
• Lead study activation, site initiation, ongoing management, and closeout across protocols.
• Monitor progress to ensure adherence to timelines, budgets, and regulatory requirements.
• Develop protocol-specific systems and study documents, including training materials and CRFs.
• Prepare and manage study budgets, collaborating with investigators and sponsors.
• Provide training, mentorship, and professional development for research staff.
• Coordinate communication with internal teams, investigators, sponsors, and external sites.
• Develop recruitment and retention strategies to support enrollment and completion.
• Ensure compliance with applicable federal, state, and institutional regulations (FDA, IRB, GCP).
• Collaborate with investigators and sponsors to support trial execution.

Kenntnisse

Leadership

Regulatory compliance

Team management

Ausbildung

Bachelor's degree in a related field

Jobbeschreibung

The University of Alabama at Birmingham (UAB) Family & Community Medicine Chair Office is seeking a Manager-Clinical Research Administration. This role oversees all clinical trial operations, manages coordinators, ensures regulatory compliance, and collaborates with internal and external sites to drive efficient trial execution.

Ideal candidates bring strong leadership, organizational, and communication skills with a proven track record in clinical research management.