Plan and perform on-site and remote audits of clinical investigation site monitoring visits (i.e. CRA Audits) by looking at all regulatory files and various site documentation required as part of TMF.
Plan and perform on-site and remote audits of clinical investigation sites and related operations and quality.
Plan and perform internal audits of the Quality Management System (QMS) and Trial Master Files (TMF).
Supports Quality System Manager in promoting and assessing compliance of contracted functions with regulations, guidelines and corporate policies and customer requirements
Provides quality assurance support, under the direction of Quality System Manager or senior staff, of assigned projects through interaction and consultation with sponsors, site, project, and study teams.
Conduct GCP, ISO and/or consultancy projects for customers, as applicable, according to departmental and/or customer policies and procedures, within budget and agreed timelines.
Participate in CAPAs including root cause analysis and reviewing corrective actions, as required.
Represent QA on sponsor/project teams, under the direction of Quality System Manager.
Working knowledge of ISO 9001:2015
Provide support during the hosting of sponsor audits and mock regulatory inspections. May host sponsor audits and work with responsible parties to prepare corrective action plan as applicable.
Provide input to interpretation, support, and training for interpretation of regulations, guidelines, corporate standards and policies.
Assists with and documents audits of Quality Assurance Policies in accordance with written audit plans to check for adherence to the Quality System.
Assists with requested reviews of project-related and non-project-related work products to check for adherence to SOPs.
Prepares regular written and oral status reports for Quality System Manager.
Perform trend analysis of QMS data
Conduct of job responsibilities in accordance with current regulations including, but not limited to FDA, ICH, and ISO.
Periodically review SOPs against current regulations including, but not limited to FDA, ICH, and ISO.
Perform other related duties as assigned.
This position may involve approximately 25% travel and requires a person who works effectively with clinicians, clients, vendors, FDA Inspectors, and staff.
Bachelors' Degree in Science, Quality Engineering, or related field.
CRA Experience and/or site monitoring experience is required in order to be effective at this role. Candidate should have a working experience with TMF/eTMF and site documentation requirements.
2-3 years related clinical QA experience in the CRO, device, pharmaceutical, or biotech industry. Working knowledge of current GCP regulations, guidelines, and related auditing techniques.
This position is mostly remote but NOT 100% remote. Candidates are expected to live within a driving distance from the office and commute to the office at times of need.