Research Regulatory Coordinator I

Arizona Liver Health•Tucson, AZ

21h•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.

Requirements

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.
High School Diploma or GED required.

Nice To Haves

Regulatory experience, preferably in sponsor-led Clinical Research, preferred.

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.
Coordinate Compliance Onboarding for new hires; this includes initial communication with new hires, collection and filing of compliance credentials, routing and tracking study trainings & delegations; collaboration with Compliance Engineer, Regulatory Staff and Research Managers.
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.
Maintain Delegation Logs.
Communicate with third parties.
Basic IRB Submissions.
Accurately file all regulatory documents.
Distinguish reportable protocol deviations.
Assist with monitoring visit.