Atlantic Research Group is a niche CRO specializing in orphan, rare and personalized drug development who is highly committed to our clients, boasting a 90% plus repeat customer rate. Our work culture is a balance between serious scientific problem solving and a relaxed environment that rewards both teamwork and individual efforts. ARG offers a competitive salary and profit sharing, a comprehensive benefit package and complete support from our managing partners.
ARG is currently looking for an full-time experienced GCP Quality Assurance Auditor to join our growing team. The QA Auditor is responsible for conducting various types of routine and for cause audits including: site audits, trial master file audits, vendor audits, internal process audits, training audits, computer system validation audits, and database audits.
- Conduct various routine and for cause audits including but not limited to site, trial master file, vendor, system validation and internal process audits.
- Document audit findings within ARG’s proprietary clinical trial management system.
- Conduct audits to ensure compliance with local and federal regulations, ICH GCP, protocol and ARG or Sponsor’s Standard Operating Procedures.
- Facilitate and participate in project team meetings to develop appropriate resolution plans or CAPAs.
- Serve as a regulatory reference for ARG staff.
- Travel as necessary for conducting audits.
- BA, BS or MS in bioscientific, healthcare or life sciences preferred
- Previous auditing experience required
- Experience in site audits preferred
- Experience as an onsite clinical monitor is a plus
- Superior clinical auditing and monitoring skills
- Excellent decision making skills and sound judgment
- Current and working knowledge of Federal Regulations, ICH /GCP guidelines
- Thorough understanding of medical terminology and human physiology
- Strong technical knowledge and ability to learn new systems quickly
- Excellent oral/presentation and written communication skills
- Ability to complete tasks efficiently and resolve problems within set timelines
- Excellent client and customer service skills
- Ability to mentor and instruct through audits
- Strong organizational skills and attention to detail
- Demonstrated flexibility and adaptability
- Ability to work in a team environment and independently as needed
ARG is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. ARG also complies with all work authorization and employment eligibility verification requirements and is an E-Verify employer.