The Quality Assurance Auditor I will be responsible for conducting quality assurance audits in the evaluation of Rho, investigator, and vendor systems and procedures to ensure compliance with regulatory requirements and ICH GCP principles. Experience with computer system validation (CSV) audits is preferred, along with an ability to represent Rho in a professional and positive manner while providing quality assurance (QA) support to both internal and external customers.  

• Working, current knowledge of regulatory requirements, ICH GxP principles, with a focus on GCP, and clinical trial processes 

• Plan, schedule, conduct, report, and close audit activities to assess compliance with applicable GxP regulations, customer requirements, Rho SOPs and project specific guidelines and instructions    

• Supporting and/or conducting audit activities including client audits, clinical site audits, key document audits, database audits, trial master file audits, and software and system validation documentation audits 

• Supporting and/or conducting audits of clinical trial vendors providing services such as central imaging, central laboratory services, ECG, IP management and distribution, IRT, ePRO/eCOA and EDC systems 

• Supporting and/or conducting internal audits of Rho. Evaluating internal compliance with company procedures, policies, programs, initiatives, GCP, and applicable regulations (internal system and process audits) 

• Assisting in the creation, review, and revision of procedural documents  

• Clearly communicating and reporting (verbally and in writing) audit outcomes and escalating significant compliance concerns to project teams, QA and Rho management and client contacts appropriately. 

• Providing regulatory compliance guidance and quality improvement consult to internal and external customers  

• Reporting, managing, and following deviations, complaints, issues, non-conformances, and their related CAPAs 

• Employing risk identification and mitigation strategies related to identified and potential compliance issues 

• Collaborating with staff members, QA, and business functions on validation of new system 

• Ensuring a high level of communication and customer service both internally and externally 

• Ability to maintain a high level of confidentiality 

• Takes initiative to complete responsibilities with minimal supervision 

• Other duties as assigned.   

• Bachelor’s degree in science or a related field and at least 2-5 years of experience actively supporting and/or conducting GCP audits; or an equivalent combination of relevant and preferred education, GCP audit certification, and/or work experience.
• Prior GCP auditing experience within the clinical research industry, including CSV experience is strongly preferred. 
• Skilled at MS Word, Excel, PowerPoint and other similar tools. Experience with SharePoint and an eQMS is preferred 
• Effective organizational, analytical, and decision making skills 
• Ability to manage multiple, concurrent ongoing projects and deadlines 
• Excellent written and oral communication skills 
• Strong attention to detail and excellent problem solving skills 
• Ability to initiate tasks and to work independently 

A few more things to know about us:

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $70,000-$85,000 per year.

EOE. Veterans/Disabled

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