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Sansum Diabetes Research Institute · 1 month ago

Quality Assurance and Regulatory Compliance Associate

Santa Barbara, California, United States

Full-time

Onsite

Mid Level

$85K/yr - $115K/yr

3+ years exp

Sansum Diabetes Research Institute is focused on advancing diabetes research, and they are seeking a Quality Assurance and Regulatory Compliance Associate. This role is responsible for developing and maintaining quality systems and regulatory compliance for human subject research, ensuring adherence to various regulations while serving as a liaison among research operations, sponsors, and regulatory authorities.

Health CareMedical

Responsibilities

Maintains regulatory compliance in all research activities in accordance with FDA, ICH-GCP, and OHRP regulations

Prepares, submits, and maintains regulatory documents including IND/IDE applications, annual reports, and study-specific submissions to regulatory agencies

Oversees and maintains Federal-wide Assurance (FWA) documentation and IRB registration

Manages clinicaltrials.gov entries under direction of Principal Investigators

Tracks and maintains documentation of research staff qualifications, training, licenses, and certifications

Oversees study record retention and archiving in accordance with FDA Title 21 CFR 312.62(c), including destruction schedules and offsite storage utilization

Maintains SDRI’s SOPs and guidelines to ensure compliance and consistency in research conduct, engaging subject matter experts in SOP development and revisions

Serves as Human Protections Associate and ensures ethical conduct and regulatory compliance in all research activities

Establishes and leads a quality assurance program that monitors compliance with regulatory requirements, GCP, and internal SOPs

Conducts internal quality audits of informed consent forms, source documentation, and regulatory binders for completeness and accuracy

Identifies and manages protocol deviations, noncompliance, and CAPAs (Corrective and Preventive Action Plans)

Supports preparation for and participation in external inspections (FDA, sponsor, CRO, IRB) and leads post-inspection follow-up and documentation

Provides guidance on risk management and continuous process improvement

Develops and maintains systems for study tracking, project management, and performance reporting

Partners with IT and operations to ensure secure management of regulatory documents within systems such as Microsoft 365 and Veeva SiteVault

Provides training and quality assurance support to research staff

Develops and delivers GCP, compliance, and SOP training sessions

Collaborates with Human Resources and leadership to ensure HIPAA and research ethics training compliance

Supports staff management and supervision as requested by the Director of Research Operations

Serves as HIPAA compliance liaison, ensuring privacy and data protection practices are upheld across research activities

Partners with Managed Services Providers and HR to maintain security and privacy SOPs, staff training, and documentation of compliance

Maintains records of publications, abstracts, and clinical trial submissions

Reports issues of noncompliance to executive leadership and Human Resources

Attends and contributes to departmental and organizational meetings

Performs other duties as assigned

Qualification

FDA regulationsICH-GCP complianceQuality managementRegulatory document managementInternal auditingClinical research experienceRegulatory certificationMicrosoft Office proficiencySpanish proficiencyCommunication skillsOrganizational skillsCritical thinkingDetail-orientedProblem-solving

Required

Working knowledge of FDA, ICH-GCP, OHRP, HIPAA, and related research regulations

Strong experience in quality management, internal auditing, and inspection readiness

Ability to interpret and apply regulatory requirements to operational processes

Excellent communication, organizational, and critical thinking skills

Ability to lead, train, and collaborate effectively across teams

Detail-oriented with excellent documentation and problem-solving abilities

Proficiency with Microsoft Office and regulatory document management systems (e.g., Veeva SiteVault)

Bachelor's degree required

The ability to read, write and speak English clearly is required

The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired