Clinical Quality Specialist
Job Title: Clinical Quality Specialist
Reports to: Director Quality Assurance
Position Purpose: The Clinical Quality Specialist (CQS) will support quality systems for Sanaria’s Clinical Department, including internal activities (standard operating procedures, documentation, internal audits) and external activities (quality review of clinical sites and contractors) as they relate to Sanaria-sponsored Phase 1 to Phase 3 clinical trials. Throughout each aspect, the CQS will ensure the implementation and management of quality systems within the Clinical Department and throughout the lifecycle of each Sanaria-sponsored clinical trial to ensure adherence to the applicable US Code of Federal Regulations (CFR), the International Council on Harmonization - Good Clinical Practice (ICH-GCP) and EU Directive quality standards required for conducting clinical trials. The CQS will report to Director, QA and will work closely with and follow the systems in place for Quality, Clinical and Regulatory Departments at Sanaria.
Essential Duties and Responsibilities:
Clinical Quality Duties and Responsibilities
- Creation, review and updating of all Clinical Department Standard Operating Procedures (SOPs) in accordance with Sanaria Quality Systems.
- Conduct and/or assist in all internal clinical quality audits, including internal adherence to SOPs, computer system validation, etc.
- Conduct, assist and/or oversee external audits (e.g. audits of external vendors or clinical sites, etc.); work with the Clinical Department and contract auditors as necessary and assist in the drafting of audit plans, confirmation letters and agendas, etc.
- Ensure adherence to the applicable US CFR, ICH-GCP and EU Directive quality standards; identify potential systemic gaps and non-compliance, and coordinate the response with the appropriate stakeholder to ensure timely remediation.
- Facilitate and review the Clinical Department’s response process to internal and external audits and inspections. Review the responses and actions performed to address findings through the corrective action and preventative action (CAPA) process. Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending.
- Work closely with the Clinical Department and Quality Systems to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of CAPA plans, as necessary.
- Ensure adequate and up-to-date training and oversight of the Clinical Department members as it relates to GCP and SOP training, etc.
- Provide Quality Assurance (QA) of trial master files (TMFs) prior to TMF closeout and archiving.
- Provide QA review of clinical trial related documents as necessary, including clinical Protocols, Amendments, Informed Consent Forms, Clinical Study Reports, etc.
- Provide QA review of clinical data including clinical immunology data and clinical reports in compliance with Sanaria SOPs.
- Draft Quality Management Plans and Risk Management Plans for individual clinical trials per ICH GCP Section 5.0.
- Evaluate clinical trial adherence according to each individual Quality Management Plan and Risk Management Plan.
- Assist with inspection readiness, and regulatory inspections as needed.
- Assist with developing training presentations on quality assurance for investigational sites and for the Sanaria clinical team.
- Assist with clinical site quality management as needed; may include review of site CAPAs, deviation reporting compliance, etc.
- Assist with clinical site qualifications, particularly in respect to the quality systems in place.
Additional Duties and Responsibilities:
- Participate in departmental and cross-departmental meetings and provide guidance to Clinical Department staff based on interpretation of current regulations to ensure best practices including risk-based management.
- Perform a global review of study data individually and across trials; investigate inconsistencies within and across individual databases and reconcile any inconsistent findings.
- Perform other reasonable duties assigned by management.
- Knowledge and Abilities (required):
- Understanding of Sanaria’s mission, objectives and values
- Knowledge of study conduct and drug/biologic development process for Phase 1-3 clinical trials conducted under US Investigational New Drug Applications (INDs), from pre-initiation through study closure and final data analysis.
- Expert knowledge of ICH-GCP guidelines, US Code of Federal Regulations, and US FDA guidance documents as they relate to Quality Management and Quality Systems
- Expert knowledge of good documentation practices (GDP) and version control
- Experience in quality management including quality audits, authoring SOPs and use of a risk-based quality management approaches
- Ability to work independently while maintaining project timelines
- Education, Work Experience and/or Licensure
- Required: BA/BS (Masters preferred) in a health, science or computer science related field
- Required: 3-5 years working in clinical research of pharma or device industry
- Required: At least 1 year working with clinical quality management systems
- Required: GCP certification
- Language Skills
- Required: Excellent oral and written communication skills
- Additional Skills
- Proficiency in Spanish is valued
- Ability to adapt to to a dynamic environment. Strong leadership and project management capabilities
- Strong organizational skills
- Mission focus
- High professional standards
- Ability to identify innovative pathways to achieve objectives
- Solid judgment, reasoning and planning
- Good listening skills, patience, and composure
- Comfortable and ability to work successfully in different countries and cultures
- Experience with TMF audits, including the use of Veeva Vault’s electronic Trial Master File (eTMF)
- Appropriate professional certification
- The position intrinsically requires the ability to travel internationally in unaccompanied fashion. It may require sufficient mobility and fortitude to conduct audits and or training at clinical sites.
- The abilities to sit, stand, walk, travel up and down stairs, crouch, stoop, reach and lift up to 25 pounds are required.
- Basic office environment.
- May require occasional domestic and international travel approximately 5-10% of the time.