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The University of Alabama at Birmingham (UAB), Department of Family and Community Medicine is seeking a Clinical Research Coordinator III to manage all aspects of assigned multi-site pragmatic clinical trials. This position will be responsible for recruitment, data collection, regulatory submissions, and ensuring data quality, as well as supporting the launch of sites for multisite studies, including conducting off-site visits and training staff on workflows. The ideal candidate will have experience in clinical research and the ability to manage complex projects while maintaining compliance with Good Clinical Practice guidelines and regulations.
General Responsibilities
To serve as a lead coordinator by providing oversight to less experienced staff to ensure quality and regulatory compliance with clinical research operations.
To coordinate and manage the research study lifecycle from start-up through close-out.
To coordinate and conduct all applicable clinical and administrative activities required by the protocol such as screening, scheduling, consenting, assessing, ordering, collecting, documenting and shipping under the auspices of Good Clinical Practice (GCP).
Key Duties & Responsibilities
Manages all aspects of assigned clinical studies, including participant recruitment, data collection, and regulatory submissions.
Develops protocol-specific processes and documents to support study implementation.
Identifies and engages various clinical, research, industry, and telehealth stakeholders to ensure adequate implementation and testing of study aims.
Assess and recommends solutions for operational challenges in data procurement.
Maintains familiarity with and ensure compliance with appropriate GCP guidelines and regulations.
Develops study standard operating procedures for recruitment, data collection, and entry.
Recruits patients for multiple clinical trials and ensure the enrollment targets are met.
Conducts data collection visits and ensure timely and accurate entry of research data.
Prepares and submits regulatory documentation, including IRB submissions, amendments, continuing reviews, and reports.
Monitors data quality and addresses discrepancies to ensure accuracy and reliability across multiple sites.
Supports launching new study sites and assist with site activation processes for multisite studies.
Leads or assists with trial-related project management and technical reporting activities.
Conducts off-site visits to provide training, monitor compliance, and ensure protocol adherence at partner sites.
Develops and manages protocol-specific systems, including training manuals, SOPs, and case report forms.
Prepares and submits study budgets, educational materials, reports, and grant renewals, as needed.
Leads or assists with team meetings to identify efficiencies and improve study processes.
Works closely with principal investigators, directors, and other stakeholders to ensure study recruitment and site expansion goals are met.
Maintains compliance with federal, state, and sponsor-specific regulations.
Performs other duties as assigned.
Annual Salary Range:$60,835 - $98,855
Qualifications
Bachelor's degree in a related field and five (5) 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 preferred.
Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center with more than $715 million in annual research funding and an economic impact on the state exceeding $12.1 billion a year. UAB is Alabama’s largest employer, with some 28,000 employees, and was named Forbes’ No. 1 Large Employer in the United States in 2021. UAB enrollment surpassed 21,500 for the fifth consecutive year in fall 2022. The university offers more than 180 degree programs in nine schools and one college. The pillars of UAB’s mission include education, research, innovation and economic development, community engagement and patient care. Learn more at www.uab.edu.