Arizona Liver Health · 2 months ago
Regulatory Coordinator II or III
Chandler, AZ or Tucson, AZ
Full-time
Onsite
Mid, Senior Level
$60K/yr - $80K/yr
4+ years expArizona Liver Health (ALH) is dedicated to advancing medical innovation through leading clinical trials and ensuring patient safety. The Regulatory Coordinator II or III will manage regulatory compliance, coordinate with research staff, and maintain regulatory documents for multi-center clinical research studies.
Clinical TrialsHealth CareHospitalityMedical
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
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
Qualification
Required
Associates Degree required
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
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
Preferred
Bachelor's degree in Regulatory Affairs, Clinical Research Management, or related preferred
Benefits
Health, Dental, Vision (with HSA plans and employer contribution)
3 weeks PTO
5 days Sick Time
7 Company holidays + 2 Half-days
401K with 6% company match
Short & Long Term Disability
Educational Assistance
Shared company vehicles for required travel
Company
Arizona Liver Health
Arizona Liver Health provides specialized diagnostics, evaluation, treatment for patients with liver disease and other liver conditions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Anita Kohli
Physician, CEO
Michelle Jones
Sr. Vice President Commercial Operations | Clinical Trial Partnerships
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