Regulatory Coordinator II or III

Arizona Liver Health•Peoria, AZ

15d•$60,000 - $80,000•Onsite

About The Position

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment. Ensures high integrity of data and patient safety at the research site through data coordination, document and regulatory management and regulatory compliance. Coordinates, assesses, plans, and facilitates Regulatory Affairs in the areas of training and compliance, system-wide use of GCP principals, and application of FDA and ICH guidelines. Implements and maintains study protocols from planning, through startup, lifecycle and closure. Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports. Understands and coordinates with the Director of clinical research, compliance with regulations as they apply to multi-center clinical research studies. Assists research staff and PIs in initiating, follow-up, negotiating, and resolving issues regarding current and future submissions Interacts with the third-party monitors for regulatory compliance and responds to regulatory queries. Executes and maintains a system for maintenance of all regulatory documents, including study-specific regulatory binders. Execute and maintain online database for tracking all study documents. Reviews sponsor guidelines for each study to ensure compliance with SOP; suggest modifications as necessary for compatibility. Liaison with the IRB to resolve questions and/or concerns Accurately file all regulatory documents within 5 Business days Distinguish reportable protocol deviations Study Start Up Assist with monitoring visit and ability to complete action items Create and Maintain Delegation of Authority Logs Conduct and complete Close out Visits Basic ICF Revisions Communicate with Third Parties with the ability to present current ILH Processes/Policies

Requirements

Knowledge to complete all IRB Submissions
Knowledge of local, state and federal regulations that apply to human subject’s research, including FDA, ICH and GCP regulations, sponsor guidelines and all SOPs.
Knowledge of protocol specific and IRB specific reporting guidelines for protocol deviations, serious adverse events and other reportable events.
Basic knowledge of Study Protocols
Ability to find/resolve regulatory issues
Associates Degree required, Bachelor's degree in Regulatory Affairs, Clinical Research Management, or related preferred
Training (appropriate to anticipated duties study-specific training, or other as applicable to assigned responsibilities).
Minimum 4 years Regulatory experience, preferably in sponsor-led Clinical Research

Responsibilities

Ensures high integrity of data and patient safety at the research site through data coordination, document and regulatory management and regulatory compliance.
Coordinates, assesses, plans, and facilitates Regulatory Affairs in the areas of training and compliance, system-wide use of GCP principals, and application of FDA and ICH guidelines.
Implements and maintains study protocols from planning, through startup, lifecycle and closure.
Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports.
Understands and coordinates with the Director of clinical research, compliance with regulations as they apply to multi-center clinical research studies.
Assists research staff and PIs in initiating, follow-up, negotiating, and resolving issues regarding current and future submissions
Interacts with the third-party monitors for regulatory compliance and responds to regulatory queries.
Executes and maintains a system for maintenance of all regulatory documents, including study-specific regulatory binders. Execute and maintain online database for tracking all study documents.
Reviews sponsor guidelines for each study to ensure compliance with SOP; suggest modifications as necessary for compatibility.
Liaison with the IRB to resolve questions and/or concerns
Accurately file all regulatory documents within 5 Business days
Distinguish reportable protocol deviations
Assist with monitoring visit and ability to complete action items
Create and Maintain Delegation of Authority Logs
Conduct and complete Close out Visits
Basic ICF Revisions
Communicate with Third Parties with the ability to present current ILH Processes/Policies