Quality and Regulatory Associate

Summary

The Quality /Regulatory Associate will perform independent examination (i.e., audit) of multiple trial related activities and documents, to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to the protocol, standard operating procedures (SOPs), GCPs and the reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.).

The Quality/Regulatory Associate is responsible for building and maintaining effective working relationships with internal staff/external vendors. The ideal candidate will be responsive, thoughtful, self‑motivated, highly organized, and a team‑player. This role reports directly to the VP of Compliance.

Under supervision of a mentor/coach, the Quality/Regulatory Associate will be responsible for:

• Responsible for quality control checks on study documents related to the conduct of the clinical trial in different therapeutic areas and phases
• Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements)
• Will also support training for site staff, this include creating and presenting quality content.
• Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, Data Services)
• Assist with writing QA audit or QC reports
• Works with internal clinical research team to ensure that inspection findings are clearly communicated and understood
• Evaluates inspection finding responses to ensure they are written to address the findings appropriately
• Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced
• Introduction to in‑life audits, process audits, and vendor audits
• Identifies and communicates opportunities for process improvement based on audit and inspection observations
• Maintains necessary documentation of QA records and study files
• Notifies management of observed quality and compliance trends in the areas inspected
• Interprets GCP, and associated regulatory documents to facilitate auditing and process improvement recommendations
• Carries out appropriate self‑development efforts as directed
• Performs other related duties as assigned

• Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to the conduct of clinical pharmaceutical and device protocols
• Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures
• Works under limited supervision to assure compliance with federal regulations relating to human subject research
• Understands and applies 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
• Prepares, maintains, and provides oversight to all research‑related regulatory documents
• Populates and coordinates the entire process of initial regulatory documents' submission to the IRB, sponsors, and state or federal regulatory offices as necessary
• Compiles study information and submits initial, continuing, and final reports to the IRB and/or sponsor
• Prepares applicable submission forms and submits updated documents, including but not limited to amendments, addendums, investigator's brochures, safety information, form FDA 1572s, and informed consent documents
• Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records
• Prepares for monitoring visits and audits
• Manages and updates employee…