**Clinical Quality Specialist (hybrid)** **Responsibilities:** • Support Clinical study team on the development of Quality Control Plans and perform implementation of quality control activities for assigned projects according to agree upon timelines • Conduct Quality Control activities which include, but are not limited to the following: o Support Quality reviews of clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations. o As applicable, review quality of Study Reports and Publications to confirm that the study was performed in accordance with the agreed upon protocol, regulatory requirements and that the clinical study is accurately and completely reported o Review of Trial Master File to ensure accuracy and completeness of the documentation. o Perform and/or support the implementation of integrated and comprehensive data-driven QC activities to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness. o Support Clinical R&D preparation, conduct and response to internal and external audits. o Prepare periodic quality control reports for assigned clinical projects, identify areas of risk and review, and communicate trends with Clinical Trial Core teams. o Using available systems tools (e.g., EDC, CTMS and eTMF generated dashboards and reports), support compilation of monthly project performance metrics for department by organizing, analyzing, preparing presentation, and facilitating Clinical Management Review (CMR) meeting. o Identify problems through analysis of project performance metrics and, with support of Quality Systems Leader, recommend corrective and preventive action (CAPA) based on knowledge of applicable regulations; ensure completion of CAPAs generated through internal and external audits. o Support Clinical R&D CAPA resolution by taking ownership, when applicable, on the corrective and preventative actions; track and ensure timely resolution of all Clinical R&D CAPAs. o Actively engage and collaborate with Clinical Trial Managers/Leaders and other members of the Clinical R&D, as applicable, to resolve any identified issues/problems. o May visit sites with Monitors to improve site performance as necessary. o Participate in/support FDA BIMO audit preparation and execution. • Responsible for tracking training/updating curriculums for all Clinical R&D associates, working with the relevant associates across the campus sites to ensure compliance with all training requirements. • May be involved in other tasks to support Clinical R&D, as needed. • Participate in Clinical Trial/Study Core Team meetings, as required. • Provide internal communication of important clinical data and event. • Establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders. • Participate in departmental initiatives across the Clinical R&D aimed at improving process and efficiency, for the improvement of local processes • Support Quality Systems Leader in ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance. • Participate in project management meetings and provide an overview of clinical quality and workload as needed. **Experience and Education:** • Minimum Bachelors/University degree with 4-6 years of experience or equivalent required. Master’s with 3 years or PhD/MD/PharmD with 1 years of relevant experience preferred • Relevant industry certifications preferred (i.e., CCRA, RAC, CDE) • Requires understanding and application of GCP regulations and standards applied in clinical areas and MedTech/combination products • Clinical/medical background - desired • Requires at least 1 year of Clinical Quality Control/Assurance experience (MedTech and pharma - desired, CRO monitoring experience – desired) **Required Knowledge, Skills:** • Knowledge and understanding of GCP (including ICH-GCP), applicable FDA regulations, EU Directive, and ISO 14155 • Understanding of quality control application in clinical research • Knowledge and understanding of the processes involved in conducting a clinical trial • Excellent interpersonal, communication and presentation skills • Change Management As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly ® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.