CLINICAL RESEARCH REGULATORY COORDINATOR III
University of Alabama at Birmingham, University, FL, United States
CLINICAL RESEARCH REGULATORY COORDINATOR III (T234510)
The University of Alabama at Birmingham (UAB), Psych - Behavioral Neurobiology is seeking a Clinical Research Regulatory Coordinator III.
This position ensures research protocol consistency and adherence, data accuracy and quality, and regulatory compliance across nine different study sites for a national, federally‑funded clinical trial involving more than 5000 participants.
This role works closely with the Principal Investigator, Study Coordinator, and Data Manager to complete monitoring and auditing to provide quality assurance of trial data. It includes regular site monitoring visits and audits across the nine national study locations, guiding a research team of more than 200 individuals to ensure compliance with institutional, sponsor, and federal requirements.
Travel to sites is expected 1 to 2 times per month for an average of 1‑2 days per visit or 1 week per month.
This position is fully remote.
General Responsibilities
Prepare and submit multiple levels of research documentation (e.g., IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
Lead the implementation of study‑specific regulatory processes of moderate to complex nature.
Conduct internal quality assurance audits of regulatory files, programs, reports, and teams within clinical trial operations.
Design and implement quality initiatives ensuring effective and efficient clinical processes.
Key Duties and Responsibilities
Support monitoring and auditing of quality assurance processes and provide guidance to research teams to ensure adherence to institutional and federal requirements.
Provide ongoing remote clinical monitoring assistance to study sites.
Provide recommendations and documentation to files, and be available for internal audits.
Handle protocol‑related clinical queries from sites and address delinquent queries for missing data.
Provide ongoing protocol training and support to clinical sites.
Monitor and review all central evaluations, sending them to study sites as needed, and summarize protocol requirements as necessary.
Conduct site qualification, initiation, monitoring, and close‑out visits in accordance with study protocols and regulatory requirements; assist in site activation activities and provide ongoing site management support.
Support investigators and site staff with training and guidance on study procedures.
Ensure the quality and regulatory compliance of clinical research activities assigned to studies or programs.
Analyze study site metrics reports to identify potential areas of concern and bring them to the supervisor’s attention.
Prepare/draft documents for IRB; work with the regulatory specialist whenever changes to the informed consent document are required—QOL review and site queries.
Collaborate with cross‑functional teams (Data Management, Quality) to maintain high‑quality trial conduct.
Identify and escalate protocol deviations, data integrity issues, and safety concerns.
Maintain study files and documentation, ensuring compliance with the manual of operations.
Ensure data security provenance; provide recommendations and documentation for internal audits.
Verify source data and ensure accuracy, completeness, and consistency with case report forms (CRFs) and study databases.
Review monitoring reports and follow‑up letters to ensure timely resolution of issues; track study metrics such as site start‑up, investigator/site performance, recruitment, regulatory documents, and QC activities, elevating areas of concern to the supervisor.
Perform other duties as assigned.
Annual Salary Range:
$55,180 - $89,670
Qualifications
Bachelor's degree in a related field and five years of related experience are required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification is preferred.
Preferences
Bachelor's degree or higher in Psychology is preferred.
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.
Shift: Day/1st Shift
Work Arrangement: Remote/Hybrid Eligible
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The University of Alabama at Birmingham (UAB), Psych - Behavioral Neurobiology is seeking a Clinical Research Regulatory Coordinator III.
This position ensures research protocol consistency and adherence, data accuracy and quality, and regulatory compliance across nine different study sites for a national, federally‑funded clinical trial involving more than 5000 participants.
This role works closely with the Principal Investigator, Study Coordinator, and Data Manager to complete monitoring and auditing to provide quality assurance of trial data. It includes regular site monitoring visits and audits across the nine national study locations, guiding a research team of more than 200 individuals to ensure compliance with institutional, sponsor, and federal requirements.
Travel to sites is expected 1 to 2 times per month for an average of 1‑2 days per visit or 1 week per month.
This position is fully remote.
General Responsibilities
Prepare and submit multiple levels of research documentation (e.g., IRB submissions, educational materials, reports, grant renewal reports, and study forms).
Prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
Lead the implementation of study‑specific regulatory processes of moderate to complex nature.
Conduct internal quality assurance audits of regulatory files, programs, reports, and teams within clinical trial operations.
Design and implement quality initiatives ensuring effective and efficient clinical processes.
Key Duties and Responsibilities
Support monitoring and auditing of quality assurance processes and provide guidance to research teams to ensure adherence to institutional and federal requirements.
Provide ongoing remote clinical monitoring assistance to study sites.
Provide recommendations and documentation to files, and be available for internal audits.
Handle protocol‑related clinical queries from sites and address delinquent queries for missing data.
Provide ongoing protocol training and support to clinical sites.
Monitor and review all central evaluations, sending them to study sites as needed, and summarize protocol requirements as necessary.
Conduct site qualification, initiation, monitoring, and close‑out visits in accordance with study protocols and regulatory requirements; assist in site activation activities and provide ongoing site management support.
Support investigators and site staff with training and guidance on study procedures.
Ensure the quality and regulatory compliance of clinical research activities assigned to studies or programs.
Analyze study site metrics reports to identify potential areas of concern and bring them to the supervisor’s attention.
Prepare/draft documents for IRB; work with the regulatory specialist whenever changes to the informed consent document are required—QOL review and site queries.
Collaborate with cross‑functional teams (Data Management, Quality) to maintain high‑quality trial conduct.
Identify and escalate protocol deviations, data integrity issues, and safety concerns.
Maintain study files and documentation, ensuring compliance with the manual of operations.
Ensure data security provenance; provide recommendations and documentation for internal audits.
Verify source data and ensure accuracy, completeness, and consistency with case report forms (CRFs) and study databases.
Review monitoring reports and follow‑up letters to ensure timely resolution of issues; track study metrics such as site start‑up, investigator/site performance, recruitment, regulatory documents, and QC activities, elevating areas of concern to the supervisor.
Perform other duties as assigned.
Annual Salary Range:
$55,180 - $89,670
Qualifications
Bachelor's degree in a related field and five years of related experience are required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification is preferred.
Preferences
Bachelor's degree or higher in Psychology is preferred.
UAB is an Equal Employment/Equal Educational Opportunity Institution dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, sex (including pregnancy), genetic information, age, disability, and veteran's status. As required by Title IX, UAB prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to UAB's Assistant Vice President and Senior Title IX Coordinator. The Title IX notice of nondiscrimination is located at uab.edu/titleix.
Shift: Day/1st Shift
Work Arrangement: Remote/Hybrid Eligible
#J-18808-Ljbffr