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As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US. We are currently seeking an Operational Quality Specialist to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.) This is a full-time, office/clinic-based job in Madison, WI. Work hours: Mon-Fri, 8am-4pm with flexibility to come in early or stay later depending upon clinical trial needs. If you join us, you will work with some of the worlds leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug. WHAT YOU WILL DO: The Operational Quality Specialist ensures that all practical aspects of clinical studies are conducted with the highest quality standards and in full compliance with study protocols, SOPs, and ICH/GCP guidelines. This role provides leadership, training, coaching, and mentoring to study staff, while proactively driving continuous improvement in operational practices. The specialist interprets external regulatory requirements and develops practical, compliant solutions. They collaborate cross-functionally to resolve issues and represent Fortrea during regulatory inspections and client audits. Other key responsibilities:
Interpret GCPs, applicable GLPs, cGMPs, and related regulatory documents to support auditing and process improvement. Ensure all work aligns with study protocols and SOPs, maintaining compliance with international GCP standards. Lead Failure Mode and Effects Analysis (FMEA) activities at the site. Take ownership of assigned quality review components for clinical projects. Compile and analyze quality metrics to identify trends and areas for improvement. Support periodic client quality reviews and address ad-hoc quality findings. Draft initial Corrective and Preventive Action (CAPA) reports. Assist in managing quality operations across Clinical Research Units (CRUs). Oversee assigned CAPAs, ensuring timely closure and proper documentation in coordination with project managers. Contribute to and lead aspects of process reviews, using findings to drive process improvements and standardization. Facilitate quality discussion forums within CRUs to identify errors, share best practices, and implement improvements. Collaborate with Clinical Pharmacology Services (CPS) and QA teams to support client audits and regulatory inspections. Promote and implement consistent, efficient, and high-quality processes to meet project timelines and deliverables. Perform additional support activities such as tracking metrics, conducting QC checks, training, and data reconciliation. Analyze operational data and recommend strategies for process improvement and operational excellence. Review data analyses and lead initiatives to enhance quality and efficiency. Perform other duties as assigned.
YOU NEED TO BRING...
At least 4 years of experience in the CRO industry, primarily in Phase I clinical trials, strongly preferred Familiarity with Quality Assurance principles. Experience generating quality metrics, performing trend analysis, and managing CAPA reports. Proficiency in Microsoft Office applications. Strong knowledge of GCP, GMP, and applicable FDA/EU regulatory guidelines. Excellent written and verbal communication skills. Ability to interpret study protocols and operational SOPs. Familiarity with Quality Assurance principles. Proficiency in Microsoft Office applications.
The important thing for us is you are comfortable working in an environment that is:
Fast paced: where no deviations from the study protocol are allowed and not meeting a timeline for even a few minutes will create a quality issue. Changing priorities constantly asking you to prioritize and adapt on the spot. Teamwork and people skills are essential for the study to run smoothly. Technology based. We collect our data directly into an electronic environment.
What do you get?
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) 401(K) Paid time off (PTO) Employee recognition awards Multiple ERG's (employee resource groups)
Learn more about our EEO & Accommodations request here.
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Fortrea
paid time off, 401(k)
Jul 24, 2025