In this position, the QA Specialist will support the ProTrials Quality Assurance department. The QA Specialist will maintain the ProTrials’ Controlled Document System and ProTrials Training Program, and other QA supportive Good Clinical Practice (GCP) activities per ProTrials procedures and applicable regulatory requirements (FDA, ICH, etc.). The QA Specialist will participate during Sponsor audits and/or regulatory inspections, as required. Responsible for assessing, evaluating, and reviewing corporate operations against GCP regulations to assure real-time observation of activities, issue identification/resolution, including proper and timely documentation Facilitates and conducts internal and external audits and provides metrics and analysis of trends based on audit findings Assist in the conduct or arrangement of GCP training for all staff Maintain the Controlled Document and Training systems and oversee administrative support utilized in maintaining systems Manage process and tracks controlled documents from the Document Change Control Form (DCRF) process until document approval or retirement, including updating related Controlled Document, training logs, and trackers Responsible for providing quality oversight to the revision, review, and approval of controlled documents Work with document reviewers to advise and revise controlled documents as appropriate and ensure reviews are performed in a timely manner Responsible for providing input and support as appropriate to the creation of new controlled documents Works with QA Management and other departments to identify gaps in controlled documents and recommends solutions Communicate effectively with staff and management across departments on status of Controlled Documents and corporate training Participate in inspection readiness activities and corporate audits, sponsor audits and/or regulatory inspections, as required Works closely with others to determine root cause and potential preventive/corrective actions in support of the corporate CAPA Program. Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations. Ensure support for the timely closure of investigations Assist QA management with the evaluation of learning management systems and other QA technology, as required Assist in the preparation of quality metrics and reports Assist QA management team with other Clinical QA activities as required Other duties, as assigned