Quality Associate

Responsibilities

• Perform independent examination (audit) of multiple trial related activities and documents to determine whether evaluated trial related activities were conducted, and data were recorded, analyzed, and accurately reported according to protocol, SOPs, GCPs, and report findings to Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.).
• Build and maintain effective working relationships with internal staff/external vendors.
• Under supervision of a mentor/coach, perform quality control checks on study documents related to conduct of clinical trial in different therapeutic areas and phases.
• Audit phases of laboratory and clinical studies, reports, and perform related duties (e.g., issue findings and QA statements).
• Support training for site staff, including creating and presenting quality content.
• Audit all disciplines (examples include Screening, Recruiting, Clinical Operations, Laboratory, Data Services).
• Assist with writing QA audit or QC reports.
• Work with internal clinical research team to ensure inspection findings are clearly communicated and understood.
• Evaluate inspection finding responses to ensure they are written to address findings appropriately.
• Ensure through phase and data inspections that SOPs involved in conduct of a study are current and practiced.
• Introduction to in-life audits, process audits, and vendor audits.
• Identify and communicate opportunities for process improvement based on audit and inspection observations.
• Maintain necessary documentation of QA records and study files.
• Notify management of observed quality and compliance trends in areas inspected.
• Interpret GCP and associated regulatory documents to facilitate auditing and process improvement recommendations.
• Carry out appropriate self-development efforts as directed.
• Perform other related duties as assigned.
• Regulatory Duties: Ensure research site follows SOPs, sponsor/CRO requirements, FDA regulations, ICH guidelines, and GCP pertaining to conduct of clinical pharmaceutical and device protocols.
• Maintain subject and document confidentiality; understand and comply with sponsor requirements, regulations including FDA, GCP, ICH, HIPAA, IRB, and institutional policies and procedures.
• Work under limited supervision to assure compliance with federal regulations relating to human subject research.
• Understand and apply ethical principles and multiple regulations to clinical research protocols.
• Review study protocols, informed consent documents, and other study-related documentation to assure conformance with all applicable requirements.
• Prepare, maintain, and provide oversight to all research-related regulatory documents.
• Populate and coordinate entire process of initial regulatory documents' submission to IRB, sponsors, and state or federal regulatory offices as necessary.
• Compile study information and submit initial, continuing, and final reports to IRB and/or sponsor.
• Prepare applicable submission forms and submit updated documents, including but not limited to amendments, addendums, investigator's brochures, safety information, form FDA 1572s, and informed consent documents.
• Accurately file and maintain all necessary logs within regulatory binder(s); assist in and manage archival of clinical trial documents/records.
• Prepare for monitoring visits and audits.
• Manage and update employee curriculum vitas and ensure copies of all current and applicable medical licenses are on file.
• Create error-free written documents and