Location: Exton, PA
Division/Department: Quality Assurance
Reports to: Manager, Clinical Quality Assurance
Job Summary
In this position the incumbent shall independently conduct a series of detailed GCP audits of Phase I – III domestic and international clinical research trials and/or GCP-related systems and processes to assure compliance with all applicable government regulations, federal guidelines, company standard operating procedures, and industry standards. Audits will be performed on external investigator sites, vendors/CROs, trial master files (TMFs), data/CRFs, study reports, and GCP-related systems/processes for clinical trials conducted by The Company.
Essential Functions
Plans, schedules, and conducts QA audits to assure adherence to company Standard Operating Procedures, and any applicable regulatory requirements.
Audits clinical investigator, trial master files, system/process, document and vendor audits/assessments.
Reviews audit responses for acceptability; elevates issues that are above incumbents abilities or that cannot be resolved.
Recommends corrective action to compliance issues and/or observations as needed to insure corrective action is implemented.
Monitors clinical operations corrective action process to insure corrective actions are being applied
Works with supervisor to develop and maintain standard operating procedures.
Provides support to management during regulatory sponsor monitor inspections, as needed.
Other projects and responsibilities may be added at the company's discretion.
Job Requirements and Qualifications
BA/BS degree in biological sciences, nursing or related discipline, or equivalent experience required
Strong knowledge of government regulations, guidelines and standards for investigation of new pharmaceutical products is required
Experience in QA audits of Clinical Investigators
Experience in QA audits of Clinical documents associated with clinical trials
Experience in system/process audits
Experience in development of SOPs
Working knowledge and understanding of drug development and global clinical regulatory environment
Ability to manage multiple projects
Effective organizational skills
Effective team player and detail oriented
Strong attention to detail, good organizational skills, ability to work independently
Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel
Knowledge Requirements:
Knowledge of the code of federal regulations, European Directives, ICH/GCP practices. The candidate will also have a working knowledge of clinical auditing processes. Previous participation in regulatory inspections is a plus.
Experience:
A minimum of 3-5 years working experience as a clinical quality assurance auditor.
Other Information
Special Information (Travel required, physical requirements, on-call schedules, and etc.):
