Quality Assurance Coordinator

CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science‑led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world‑class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work–life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment, including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary Reporting to the Regional Quality Assurance Director, this role will ensure that the highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. This role will guarantee that accepted procedures are followed, establish and maintain quality metrics and trends for the site in collaboration with site leadership, and oversee quality control oversight, deviations, CAPAs, audit findings, internal audit program management, training compliance, vendor management, risk management, and documentation control. Compensation $27–$31/h depending on experience, skillset, and education. Essential Responsibilities and Duties Assist the QA Manager in the development, implementation and follow‑up of quality assurance programs, including necessary policies and guidelines. Oversee quality control activities for the site and overall QC training. Manage the site’s yearly internal audit program in collaboration with site leadership. Review follow‑up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis to ensure any actions derived are completed and documented. Manage external audits in partnership with site leadership to ensure audit readiness. Manage vendors for the site. Provide overall training aligned to regulations and local processes as needed. Oversee training compliance for the site to maintain training requirements. Manage the site’s CAPAs upon identification to ensure due dates are attained. Perform quality review of source documentation, including amendments, to ensure all protocol‑required procedures are present. Host FDA inspections for the site in collaboration with site leadership and applicable subject matter experts. Ensure documentation and working practices are updated and reviewed at required cycles. Oversee the site’s Clinical Quality Management Plan and Business Continuity plan completion yearly. Provide the site’s quality assurance metrics reporting. Attend site initiation visits as needed. Support and ensure strict adherence to best practices, FDA Code of Federal Regulations, ICH GCP, CenExel SOPs, site working practices, protocol, and company guidelines and policies. Assume other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered all inclusive. Education/Experience/Skills Must be able to effectively communicate verbally and in writing. High school graduate or equivalent; bachelor’s degree or equivalent preferred. Minimum 1–2 years of relevant experience in the clinical research industry. Must be self‑directed and able to work with minimal supervision; have in‑depth knowledge of FDA regulations, GCP, and ICH guidelines; take a flexible approach to shifting priorities; manage multiple projects and responsibilities; remain motivated in a fast‑paced, rapidly changing environment; be detail oriented with exceptional computer, organizational, and communication skills—both written and oral. Reflect the professional image of the company, upholding its vision in actions, demeanor, and appearance. Communicate clearly through written and verbal means with sponsors and staff. Working Conditions Indoor office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr CenExel Rocky Mountain Clinical Research