Quality Assurance Consultant

Title: Quality Assurance Consultant

Location: 100% remote

Duration: 1 year contract, possible contract to hire

Compensation: $30-36/hr.

Start Date: ASAP

Joule is currently looking for a Clinical Research Quality Assurance Consultant. You will primarily responsible for providing guidance and support to Company Development Innovations or functional groups supported by Corporate Quality, as appropriate, and the Quality Management Systems (QMS) processes to meet GCP and regulatory requirements in the conduct of clinical trials. You will also manage Sponsor audits, assists in hosting regulatory inspections, and conducts internal, site and vendor audits as assigned.

Duties and Responsibilities:

• Develop and maintain effective relationships with Sponsors, Company operational leaders, operational colleagues supporting research activities and all other colleagues, as necessary

• Provide guidance to research operations on the interpretation of ICH-GCP, local and federal regulatory requirements as related to the conduct of clinical research

• Prioritize and escalate "Critical" and "Major" quality issues, identified procedural gaps

and/or other areas of deficiency. Report deficiencies to Executive and Physician leadership, where appropriate

• Manage and facilitate all external Sponsor, IRB, or other audits of Innovations, including but not limited to preparation, hosting, responding and follow-up of those deliverables resulting from the sponsor's audits

• Manage and facilitate any regulatory agency inspection of Innovations, including but not limited to preparation, hosting, triaging, responding and continued follow-up of those

deliverables resulting from the regulatory inspection

• Provide guidance and support for non-conformance resolution including root-cause analysis, corrective and preventive actions

Required:

• Bachelor's degree preferred, relevant experience may be substituted for education

• 3+ years of relevant experience

• Must have strong understanding of a quality management system that meets ISO 9001

• Must have strong understanding of ICH E6 R3

• Must have a strong understanding of KPIs, KQIs, how to collect and analyze these

• Preferred: Certified Clinical Research Professional, ASQ Certified Quality Auditor, ISO 9001 Certified Lead Auditor, or Certified Medical Device Auditor

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.