Consultant, GxP Services

Company Information 

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.  

Company Culture  

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.  

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact. 

Job Overview Summary  

The Consultant, Good Practice (GxP) Services supports the delivery of GxP consulting services for Advarra client projects under the guidance of senior consultants and consulting leadership. The Consultant assists with audits, assessments, quality assurance activities, and compliance initiatives across various GxP disciplines, but focused on Good Clinical Practice (GCP) for investigator sites. 

This role develops technical expertise while partnering with senior team members to deliver high-quality client service and project outcomes. The Consultant contributes to project deliverables, supports client engagements, and participates in continuous learning and professional development. Position requires travel up to 50% - 70%. 

Job Duties & Responsibilities  

• Support consultants in delivering GxP consulting services for pharmaceutical, biotechnology, medical device, and life sciences clients. 
• Assist with planning and conducting domestic audits and assessments under the direction of senior team members. 
• Plans and performs independent audits with SME support. 
• Supports inspection readiness activities as a co-auditor. 
• Participates in mock inspections with senior consultants. 
• Assists with SOP reviews and documentation. 
• Develops subject matter knowledge over time. 
• Supports client communications with project team 
• Participates in continuous improvement initiatives. 
• Performs consulting engagements under direction. 
• Participate in investigator site, TMF, vendor, facility, document, and systems audits. 
• Prepare audit documentation, reports, observations, and supporting project deliverables. 
• Assist with quality control reviews of project documentation and data. 
• Support inspection readiness activities, mock inspections, and compliance assessments. 
• Participate in SOP reviews, gap analyses, and quality system improvement initiatives. 
• Assist with developing client training materials and participate in delivery of GxP-related training as appropriate. 
• Collaborate with project managers and senior consultants to meet project timelines and client expectations. 
• Maintain current knowledge of applicable GxP regulations and industry best practices. 
• Support internal process improvement initiatives and perform other duties as assigned. 

Location  

This role is open to candidates working in the United States. 

Basic Qualifications  

• Bachelor’s degree in Nursing, Life Sciences, or related field (or equivalent combination of education and experience). 
• Minimum 3-5 years of experience in clinical research, quality assurance, regulatory compliance, or a related life sciences environment. 
• Ability to travel extensively. 

Preferred Qualifications  

• 1-3 years of experience supporting GxP, QA, compliance, auditing, or operational functions. 
• Experience working within pharmaceutical, biotechnology, medical device, CRO, or related industries. 
• Foundational knowledge of GCP and other applicable GxP regulations focused on investigator sites. 
• Spanish language skills – intermediate fluency. 
• Demonstrated analytical and problem-solving skills. 
• Strong written and verbal communication skills. 
• Ability to manage multiple priorities while working collaboratively within project teams. 
• Proficiency with Microsoft Office applications. 

Physical and Mental Requirements 

• Sit or stand for extended periods of time at stationary workstation 
• Regularly carry, raise, and lower objects of up to 10 Lbs.  
• Learn and comprehend basic instructions 
• Focus and attention to tasks and responsibilities 
• Verbal communication; listening and understanding, responding, and speaking  

Advarra is an equal opportunity employer that is committed to providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information, or any other status or characteristic protected by federal, state, or local law.  

Pay Transparency Statement   

The base salary range for this role is $71,000 - $125,000. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.