CLINICAL RESEARCH REGULATORY COORDINATOR III
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 9 different study sites for a national, federally-funded, clinical trial involving more than 5000 participants. This position will work closely with the Principal Investigator, Study Coordinator, and Data Manager to complete monitoring and auditing to provide quality assurance of trial data. This position completes regular site monitoring visits and any necessary audits across the 9 national study locations. They will provide guidance to the entire research team of more than 200 individuals to ensure adherence consistency in procedures as well as compliance with institutional, sponsor, and federal requirements. This position is essential to maintaining consistent procedures and standards, as well as data integrity across multiple study sites and minimizing regulatory risk.
Travel to sites/travel expected 1 to 2 times per month for an average of 1-2 days per monitoring visit or 1 week per month.
This position is fully remote
General Responsibilities
• To prepare and submit multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
• To lead the implementation of study specific regulatory processes of a moderate to complex nature.
• To conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations.
• To design and implement quality initiatives ensuring effective and efficient clinical processes.
Key Duties & Responsibilities
• Supports the monitoring and auditing of quality assurance processes and provides guidance to research teams to ensure adherence to institutional and federal requirements.
• Provides ongoing remote clinical monitoring assistance to study sites.
• Provides recommendations of notes to files, provides documentation, and is available for internal audits.
• Handles protocol-related clinical queries from sites and addresses delinquent queries to sites for missing data.
• Provides ongoing protocol training/support to clinical sites.
• Monitors and reviews all central evaluations, sending them to study sites as needed, and summarizes protocol requirements as necessary.
• Conducts site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, and regulatory requirements. Assists in site activation activities and provides ongoing site management support.
• Supports investigators and site staff with training and guidance on study procedures.
• Ensures the quality and regulatory compliance of clinical research activities assigned to studies or programs.
• Analyzes study site metrics reports to identify potential areas of concern and bring to the supervisor's attention.
• Prepares/drafts documents for IRB. Works with the regulatory specialist whenever changes to the informed consent document are required. QOL review and site queries.
• Collaborates with cross-functional teams (Data Management, Quality) to maintain high-quality trial conduct.
• Identifies and escalates protocol deviations, data integrity issues, and safety concerns.
• Maintains study files and documentation, ensuring compliance with manual
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This position ensures research protocol consistency and adherence, data accuracy and quality, and regulatory compliance across 9 different study sites for a national, federally-funded, clinical trial involving more than 5000 participants. This position will work closely with the Principal Investigator, Study Coordinator, and Data Manager to complete monitoring and auditing to provide quality assurance of trial data. This position completes regular site monitoring visits and any necessary audits across the 9 national study locations. They will provide guidance to the entire research team of more than 200 individuals to ensure adherence consistency in procedures as well as compliance with institutional, sponsor, and federal requirements. This position is essential to maintaining consistent procedures and standards, as well as data integrity across multiple study sites and minimizing regulatory risk.
Travel to sites/travel expected 1 to 2 times per month for an average of 1-2 days per monitoring visit or 1 week per month.
This position is fully remote
General Responsibilities
• To prepare and submit multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
• To lead the implementation of study specific regulatory processes of a moderate to complex nature.
• To conduct internal quality assurance audits of regulatory files as well as programs, reports, and teams working within clinical trial operations.
• To design and implement quality initiatives ensuring effective and efficient clinical processes.
Key Duties & Responsibilities
• Supports the monitoring and auditing of quality assurance processes and provides guidance to research teams to ensure adherence to institutional and federal requirements.
• Provides ongoing remote clinical monitoring assistance to study sites.
• Provides recommendations of notes to files, provides documentation, and is available for internal audits.
• Handles protocol-related clinical queries from sites and addresses delinquent queries to sites for missing data.
• Provides ongoing protocol training/support to clinical sites.
• Monitors and reviews all central evaluations, sending them to study sites as needed, and summarizes protocol requirements as necessary.
• Conducts site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, and regulatory requirements. Assists in site activation activities and provides ongoing site management support.
• Supports investigators and site staff with training and guidance on study procedures.
• Ensures the quality and regulatory compliance of clinical research activities assigned to studies or programs.
• Analyzes study site metrics reports to identify potential areas of concern and bring to the supervisor's attention.
• Prepares/drafts documents for IRB. Works with the regulatory specialist whenever changes to the informed consent document are required. QOL review and site queries.
• Collaborates with cross-functional teams (Data Management, Quality) to maintain high-quality trial conduct.
• Identifies and escalates protocol deviations, data integrity issues, and safety concerns.
• Maintains study files and documentation, ensuring compliance with manual
Apply tot his job
Apply To this Job