University of Alabama at Birmingham Looking for Manager-clinical Research Coordination – T213230 Full Time

Description

Under Dr. Aaron Fobian, the Manager – Clinical Research Coordinator will manage all aspects of the lab and research projects.

General Responsibilities

• To manage all aspects of research program and clinical studies including education/teaching.
• To oversee and manage multiple clinical research protocols and the associated personnel.
• To design best practices for management of IP for drug, device, and biologic studies.
• To prepare study budgets.
• To manage research staff within area including all applicable human resources functions.

Primary Responsibilities

• Acts as a consultant within area of clinical expertise.
• Identifies various stakeholders to ensure adequate design, implementation, and testing of study aims.
• Collects information to determine study feasibility.
• Makes recommendations to investigators and oversight organizations, as appropriate.
• Prepares and submits multiple levels of research documentation (i.e. IRB, IND, or FDA submissions, educational materials, reports, grant renewal reports, and study forms.
• Serves as a mentor to junior staff.
• Manages research staff within area including all applicable human resource functions.
• Develops and employs strategies to maintain recruitment and retention rates.
• Oversees the use of Electronic Data Capture (EDC) systems, as necessary for operations.
• Manages the development of standard operating procedures (SOPs) for data quality assurance.
• Initiates and/or assists with developing and revising policies and procedures for research staff.
• Trains staff to maintain documentation for all processes.
• Develops protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Prepares study budgets.
• Determines solutions for operational shortcomings of data procurement in protocol design.
• Identifies appropriate stakeholders to ensure adequate design, implementation, and testing of study aims.
• Assists in maintaining compliance with federal, state, and accrediting agencies (sponsors), including maintaining any required documentation.
• Plans and leads site initiation and closeout visits with sponsors.
• Employs escalation and performance plans as needed.
• Directs the performance of study audits and monitors activities to ensure compliance with all clinical and regulatory aspects of the research.
• Manages project organization including coordination of internal and external regulations and guidelines affecting clinical research.
• Independently conducts literature reviews and contributes to publications and presentations.
• Performs other duties as assigned.

Annual Salary Range – $70,425 – $114,440

Qualifications

Bachelor’s degree in a related field and eight (8) 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 strongly preferred.

Key Skills

• Organized
• Leadership skills

Primary Location: University

Job Category: Clinical Research

Organization: 311701600 Psych – Behavioral Neurobiology

Employee Status: Regular

Shift: Rotation / Flexible Staffing / Multiple Shifts

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