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Essential Job Duties:

Provide oversight of the Quality Control (QC) program across all clinical research sites and departments.
Develop, implement, and maintain quality control processes to ensure compliance with

ICH-GCP, FDA

regulations, sponsor requirements, SOPs, and company policies.

Ensure all Quality Control Analysts adhere to established Standard Operating Procedures (SOPs), Work Instructions (WIs), and Quality Management System (QMS) requirements when conducting quality control reviews of clinical research activities.
Oversee and ensure compliance with all applicable study-specific and regulatory requirements, including but not limited to study protocols, Good Clinical Practice (GCP), Good Documentation Practices (GDP), ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available), HIPAA, OSHA, FDA regulations, ICH Guidelines, and Case Report Form (CRF) requirements.

Utilize risk-based quality management principles to identify, prioritize, and mitigate operational and regulatory risks that may impact participant safety, protocol compliance, or data integrity.
Provide oversight of quality control review activities to verify the accuracy, completeness, consistency, and integrity of clinical trial documentation and source data.
Ensure quality control findings are appropriately documented in our Quality Management System (QMS), communicated, trended, and escalated, and that corrective and preventive actions (CAPAs) are implemented when deficiencies or compliance risks are identified.
Monitor and evaluate quality and compliance risks, protocol deviations, non-compliance events, quality incidents, and process trends; ensure timely documentation, reporting, escalation, resolution, and implementation of corrective actions as appropriate.
Perform quality metrics analysis and prepare periodic quality reports, trend analyses, and compliance dashboards for executive leadership.
Conduct site quality assessments, internal audits, and process reviews to evaluate adherence to regulatory and company requirements.
Support the Director of Regulatory and Compliance with inspection readiness initiatives and assist with sponsor audits, CRO audits, FDA inspections, IRB audits, and other regulatory inspections.
Collaborate with the Director of Regulatory and Compliance with the development and execution of responses to audit findings, regulatory observations, sponsor concerns, and inspection outcomes, ensuring timely implementation of corrective and preventive actions.
Collaborate with Regulatory, Clinical Operations, Research Coordinators, Research Assistants, Licensed Practical Nurses, Investigators, Pharmacy, Laboratory, Raters, and Data Entry teams to ensure quality standards are consistently maintained.
In collaboration with Subject Matter Experts (SMEs), develop, review, revise, and implement Standard Operating Procedures (SOPs), Work Instructions (WIs), training materials, and Quality Management System (QMS) documents to ensure compliance with regulatory requirements, industry best practices, and organizational quality standards.
Provide training, coaching, and ongoing guidance to staff regarding quality standards, regulatory requirements, documentation expectations, and best practices.
Monitor staff adherence to SOPs and study-specific procedures, recommending remediation and retraining when necessary.
Maintain quality records, audit trails, CAPA documentation, and inspection-ready files in accordance with company and regulatory requirements.
Manage and develop Quality Control personnel, including workload planning, performance management, training, mentoring, and professional development.
Meet regularly with each direct report throughout the year to discuss progress on goals and provide timely feedback, including objective, measurable goals.
Perform annual performance appraisals, setting annual goals and plans for each direct report.
Review applicants' resumes and conduct initial interviews for all open direct report staff positions, provide recommendations for hire, and document outcomes with Director of Regulatory and Compliance and Human Resources.
Manage paid time off and complete biweekly review and approval of payroll for direct reports.
Provide routine training to staff to develop skills related to GLP, GDP, and GCP compliance issues.
Coach, develop, and serve as a resource to direct reports for their career path.
Escalate critical non-compliance issues, significant protocol deviations, participant safety concerns, systemic quality trends, and regulatory risks to the Director of Regulatory and Compliance, President, Medical Director, and other stakeholders, as appropriate.
Provides regular reports to the Director of Regulatory and Compliance, President and/or Medical Director and Management Teams to advise leadership of quality issues and to guide enterprise process corrections & improvements.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis.

The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

OTHER SKILLS AND ABILITIES

Comprehensive knowledge of clinical research processes, regulatory requirements, and quality management systems.
Strong analytical and critical thinking skills with the ability to identify compliance risks, root causes, and process improvement opportunities.
Experience conducting quality control reviews, data verification, trend analysis, and risk assessments.
Proven ability to develop, implement, and monitor Corrective and Preventive Action (CAPA) plans.
Exceptional attention to detail with a commitment to data integrity, ALCOA+ principles, and documentation quality.
Strong leadership, coaching, and mentoring skills with the ability to build high-performing teams.
Excellent written and verbal communication skills, including the ability to effectively communicate complex regulatory and quality requirements.
Strong organizational and project management skills with the ability to manage multiple priorities and deadlines.
Ability to work collaboratively with investigators, site personnel, sponsors, CROs, and regulatory agencies.
Ensure the integrity, accuracy, completeness, and traceability of data maintained within source records, EDC systems, eSource platforms, CTMS, eRegulatory systems, and other research-related electronic systems.
Ability to maintain confidentiality and exercise sound professional judgment in handling sensitive information.
Functions well under high-pressure conditions.
Models team collaboration skills. o Works effectively and collaboratively with team members to accomplish goals.
Independently displays a passion to learn and innovate and maintains knowledge of industry development through personal readings and individual trainings.
Balances tasks with competing priorities effectively without direction from supervisor.
Solicits & responds positively to direction & constructive criticism from supervisors, managers, & peers.

REQUIREMENTS

Bachelor's degree in life Science, Healthcare Administration, Regulatory Affairs, Quality Management or related field required
Minimum 5-year experience in clinical research quality assurance, quality control, regulatory compliance, or a related field.
Minimum of 3 years of leadership experience or management experience overseeing quality and compliance activities
Strong working knowledge of ICH-GCP guidelines, FDA regulations, 21 CFR Part 11, HIPAA, and applicable federal and state regulations governing clinical research.
Previous experience working with Standard Operating Procedures development preferred
Experience preparing for, participating in, and responding to sponsor, CRO, regulatory authority, and internal audits and inspections.
Proficiency in English required
Proficiency in Spanish preferred
Training in clinical research courses preferred
Proficiency with Microsoft Office, including Outlook and Excel Key Performance Areas
Audit and inspection readiness
CAPA effectiveness and closure timelines
Protocol deviation reduction
Quality review completion timelines
Regulatory compliance metrics
Training compliance and effectiveness
Data integrity and documentation quality
Continuous process improvement initiatives
Site quality performance and trend analysis

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Paid time off Vision insurance

Education:

Bachelor's (Preferred)

Experience:

Clinical research: 4 years (Preferred)

Work Location:

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Clinical Research Quality Control Manager