MANAGER-CLINICAL RESEARCH ADMINISTRATION
University of Alabama at Birmingham · Greater Birmingham, Alabama Area · 2 mo ago
Analyst$78k–$126k/yrFull-time
General Responsibilities
- Act as a subject matter expert (SME) for faculty and staff regarding administrative duties for industry and sponsored clinical research.
- Serve as a referral resource for the clinical research community at UAB.
- Manage and maintain the study’s compliance with institutional requirements.
- Manage division-wide training in ethical conduct of research.
- Manage, assess, and determine solutions for operational shortcomings of protocols.
- Provide human resources oversight for subordinate personnel.
Key Duties & Responsibilities
- Manages and supervises clinical research coordinators and research staff, including all applicable human resource functions, across multiple ongoing and upcoming clinical trials.
- Prepares, submits, and maintains regulatory documentation, including IRB submissions, amendments, and continuing reviews, while supporting broader regulatory compliance activities as needed.
- Leads and coordinates study activation, site initiation, ongoing management, and study closeout activities across multiple clinical research protocols.
- Maintains study progress and staff activities to ensure adherence to study protocols, timelines, budgets, and all clinical and regulatory requirements.
- Develops protocol-specific systems and study documentation, including process flows, training materials, CRFs, and other operational tools.
- Prepares and manages study budgets, and collaborates with investigators and sponsors on financial planning and execution.
- Provides training, mentorship, and professional development for research staff, including assigning responsibilities, reviewing work, and identifying process improvements.
- Collaborates with internal teams, investigators, sponsors, and external research sites to ensure efficient trial operations and data integrity.
- Coordinates communication with internal teams, investigators, sponsors, and external research sites to ensure efficient trial operations and data integrity.
- Develops and implements recruitment and retention strategies to support successful study enrollment and completion.
- Ensures compliance with all applicable federal, state, and institutional regulations and guidelines (e.g., FDA, IRB, GCP).
Qualifications
- Bachelor's degree in a related field and eight (8) years of related experience required.
- Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification strongly preferred.
Pay
Annual Salary Range: $77,640 - $126,170
Schedule
Day/1st Shift
Benefits
UAB offers a comprehensive benefits package including health insurance, retirement plans, and paid time off.