Overview
Quality Inspector Jobs in Windber, PA at Kitron Technologies, Inc.
About Us:
Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team.
Position Summary:
The Clinical Research Regulatory Compliance and Quality Assurance Manager plays a critical role in ensuring that all clinical research conducted at our sites complies with FDA regulations, ICH-GCP guidelines, IRB requirements, and institutional policies. This position is responsible for overseeing regulatory submissions, maintaining site readiness, and developing internal quality systems to support high standards of clinical trial conduct. The role serves as a key resource for principal investigators, study coordinators, and monitors, and helps maintain audit readiness across all trials and sites.
Key Responsibilities:
Regulatory Compliance
Prepare and maintain essential regulatory documents (e.g., 1572s, investigator CVs, financial disclosures, protocol approvals, ICF versions) in accordance with sponsor and IRB requirements.
Submit initial study documents, amendments, safety reports, and continuing reviews to central or local IRBs in a timely manner.
Track IRB submissions and approvals, ensuring version control and compliance across patient-facing materials.
Maintain regulatory binders (physical or electronic) and ensure ongoing compliance with sponsor specifications and ICH-GCP.
Serve as site liaison during sponsor monitoring visits and audits, including regulatory document review and correction.
Monitor SOP adherence and escalate any deviations or compliance concerns to leadership with recommendations for resolution.
Implement new SOPs and updates through structured change management processes, ensuring version control and staff training.
Conduct periodic SOP reviews to incorporate new regulatory requirements, audit findings, and operational improvements.
Work closely with research leadership to standardize SOPs across all sites and ensure consistency in regulatory practices.
Review, develop, and maintain site-specific Standard Operating Procedures (SOPs) in alignment with current GCP, FDA regulations, and sponsor expectations.
Quality Assurance
Implement and oversee internal quality checks for consent documentation, source data, protocol compliance, and regulatory files.
Conduct routine internal monitoring of study conduct and documentation across all active trials.
Document protocol deviations and work with staff and investigators to ensure proper follow-up and CAPA documentation.
Support sponsor and regulatory audits by preparing documentation, assisting during visits, and coordinating corrective actions post-audit.
Maintain audit readiness across all studies through proactive documentation reviews and staff training.
Training & Oversight
Train site staff, including new coordinators, research assistants, and physicians, on GCP, informed consent procedures, and regulatory expectations.
Assist in developing and updating SOPs for research operations in collaboration with the research leadership team.
Ensure staff are current on study-specific training and protocol compliance requirements.
Cross-Functional Site Support
Collaborate with site operations staff to ensure seamless integration of regulatory activities with scheduling, enrollment, and data entry.
Communicate with sponsors and CROs to respond to queries and address regulatory requests.
Assist with feasibility and site qualification efforts by ensuring regulatory readiness for new studies.
Additional duties as assigned.
Qualifications
Education & Experience:
Bachelor’s degree in a life science, public health, or related field required (Master’s preferred).
Minimum of 5 years of experience working in clinical research at a site, with at least 1 year in regulatory or quality assurance.
Strong familiarity with IRB processes, sponsor/CRO communications, and site-level study operations.
Skills & Competencies:
Comprehensive understanding of ICH-GCP, FDA regulations, and clinical site workflows.
Excellent organizational and time management skills; capable of managing multiple protocols and priorities.
Strong attention to detail and proactive problem-solving skills.
Ability to train and mentor staff on compliance topics.
Proficient with Microsoft Office and eRegulatory platforms (e.g., Florence, Veeva SiteVault, etc.).
Excellent verbal and written communication skills.
Preferred Certifications:
Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or equivalent preferred.
Job Type: Full-time
Pay: $85,000.00 – $105,000.00 per year
Benefits:
401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Work Location: Remote
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Title: Quality Inspector
Company: Kitron Technologies, Inc.
Location: Windber, PA
