Sansum Diabetes Research Institute
Quality Assurance and Regulatory Compliance Associate
Sansum Diabetes Research Institute, Santa Barbara, California, us, 93190
Quality Assurance and Regulatory Compliance Associate
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Quality Assurance and Regulatory Compliance Associate
role at
Sansum Diabetes Research Institute
Position Summary The Quality Assurance and Regulatory Compliance Associate is responsible for developing, implementing, and maintaining quality systems and regulatory compliance for human subject research conducted at SDRI. Under the supervision of the Director, Clinical Research Operations, this role integrates regulatory oversight, quality assurance, and compliance management to ensure adherence to FDA, ICH-GCP, HIPAA, and institutional policies. The incumbent serves as a key liaison between research operations, sponsors, and regulatory authorities, providing expertise in clinical trial compliance, quality management, and staff education. This role supports inspection readiness, oversees document control and SOP management, maintains research staff qualifications, and ensures data integrity and participant safety across all studies.
Essential Duties And 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.
Training
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.
HIPAA and Privacy Oversight
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.
Additional Responsibilities
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.
Qualifications
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).
Education And Experience
Bachelor’s degree required; Master’s degree in biological/physical science or related field preferred.
Preferred minimum 3 years of experience in clinical research, with emphasis in regulatory or quality assurance.
Regulatory or clinical research certification (e.g., ACRP, SOCRA, RQAP-GCP) preferred.
Experience supporting FDA or sponsor audits strongly desired.
Language Skills 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. Spanish proficiency and/or fluency highly desired.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The incumbent is regularly required to sit, talk, hear, and climb stairs. The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files. The incumbent is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10-20 pounds. Specific vision abilities required by this job include close vision. This position requires manual dexterity, skill level and adequate vision to record data onto data sheets and adequate hearing and verbal communication skills to converse with study subjects. Standing for extended periods of time as well as light lifting is necessary.
Work Environment The work environment would be generally described as an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee’s functional activities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate and the illumination of the work area is primarily with fluorescent artificial lighting. This position is associated with exposure to biohazardous materials and communicable disease always requiring the use of universal precautions as well as other conditions common to a medical clinic and research facility.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Finance and Sales
Industries: Research
Referrals increase your chances of interviewing at Sansum Diabetes Research Institute by 2x.
Santa Barbara, CA $75,000.00-$90,000.00 1 month ago
This job description is intended to describe the general requirements of the performance of the job. It is not a complete list of duties, responsibilities or requirements. Other duties not listed here may be assigned as needed.
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Quality Assurance and Regulatory Compliance Associate
role at
Sansum Diabetes Research Institute
Position Summary The Quality Assurance and Regulatory Compliance Associate is responsible for developing, implementing, and maintaining quality systems and regulatory compliance for human subject research conducted at SDRI. Under the supervision of the Director, Clinical Research Operations, this role integrates regulatory oversight, quality assurance, and compliance management to ensure adherence to FDA, ICH-GCP, HIPAA, and institutional policies. The incumbent serves as a key liaison between research operations, sponsors, and regulatory authorities, providing expertise in clinical trial compliance, quality management, and staff education. This role supports inspection readiness, oversees document control and SOP management, maintains research staff qualifications, and ensures data integrity and participant safety across all studies.
Essential Duties And 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.
Training
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.
HIPAA and Privacy Oversight
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.
Additional Responsibilities
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.
Qualifications
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).
Education And Experience
Bachelor’s degree required; Master’s degree in biological/physical science or related field preferred.
Preferred minimum 3 years of experience in clinical research, with emphasis in regulatory or quality assurance.
Regulatory or clinical research certification (e.g., ACRP, SOCRA, RQAP-GCP) preferred.
Experience supporting FDA or sponsor audits strongly desired.
Language Skills 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. Spanish proficiency and/or fluency highly desired.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The incumbent is regularly required to sit, talk, hear, and climb stairs. The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files. The incumbent is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10-20 pounds. Specific vision abilities required by this job include close vision. This position requires manual dexterity, skill level and adequate vision to record data onto data sheets and adequate hearing and verbal communication skills to converse with study subjects. Standing for extended periods of time as well as light lifting is necessary.
Work Environment The work environment would be generally described as an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee’s functional activities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate and the illumination of the work area is primarily with fluorescent artificial lighting. This position is associated with exposure to biohazardous materials and communicable disease always requiring the use of universal precautions as well as other conditions common to a medical clinic and research facility.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Finance and Sales
Industries: Research
Referrals increase your chances of interviewing at Sansum Diabetes Research Institute by 2x.
Santa Barbara, CA $75,000.00-$90,000.00 1 month ago
This job description is intended to describe the general requirements of the performance of the job. It is not a complete list of duties, responsibilities or requirements. Other duties not listed here may be assigned as needed.
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