CLINICAL RESEARCH ADMINISTRATOR II

at  University of Alabama at Birmingham

Description
The University of Alabama at Birmingham (UAB), Department of Med - Infectious Diseases, is seeking a Clinical Research Administrator II.
This position will be a key member of a clinical research team with a diverse research portfolio of clinical trials focused on the treatment and prevention of infection in women and pregnancy. They will work collaboratively as part of a multidisciplinary global team to manage clinical trials and studies in the US and Africa with tasks that include: coordination of research activities with supportive partners focused on study design and conduct, regulatory issues, database management, investigational pharmacy, sample collection and processing and dissemination of study results. Provides data for the creation of study budgets as needed. Leads development of standard operating procedures for data quality assurance.

GENERAL RESPONSIBILITIES

• To demonstrate a comprehensive understanding of contract principles, federal regulations, laws and UAB policy and operating procedures.
• To serve as liaison to the UAB Offices of Industry Engagement and Sponsored Programs in negotiation of confidentiality agreements (CDAs), contracts, and amendments related to the conduct of clinical research activities.
• To identify conflicts of interest, legal, IP and business/financial risk.
• To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.

KEY DUTIES & RESPONSIBILITIES

• Serves as a liaison with research study staff, University Departments, and community partners.
• Prepares and submits multiple levels of research documentation (i.e., IRB; NIH reports; recruitment, consent, and data collection materials; grant renewal reports; and study forms).
• Organizes and leads team meetings with academic, research, and community partners.
• Takes and distributes meeting minutes in conjunction with Investigators, plans and implements the clinical protocol’s goals and objectives.
• Comprehends and monitors project milestones.
• Compiles, edits, and proofs written reports for project teams and internal and external administrative offices.
• Leads development of standard operating procedures for data quality assurance.
• Under the oversight of the Investigator, develops protocols, identifies efficiencies, and improves processes.
• Maintains compliance with federal, state, and accrediting agencies (sponsors).
• Maintains any required documentation.
• Provides data for the creation of study budgets as needed.
• Research and develop options for unique challenges.
• May supervise junior staff.
• Performs other duties as assigned.
  Annual Salary Range: $47,665 - $77,455
  Qualifications
  Bachelor’s degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.
  Primary Location: University
  Job Category: Clinical Research
  Organization: 311402400 Med - Infectious Diseases
  Employee Status: Regular
  Shift: Day/1st Shift
  Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite