West Bend, Wisconsin
Clinical Compliance Coordinator Job Opening in West Bend, Wisconsin - Spaulding is growing and we have an opening for a full time Clinical Compliance Coordinator. This role is focused around quality and process improvement. We are looking for an individual who is well versed in healthcare compliance to assist us in our pursuit for quality perfection. If you have prior experience working in a similar highly regulated field and a strong background in quality/training this role might be the perfect fit for you!
Position Snapshot:
Full Time M-F 8am-5pm (Occasional weekends may be necessary)
Health, Dental, Vision, Life, Short/Long Term Disability Insurance
Generous Paid Time Off
10 paid Holidays
401k
Eligible for summer flex hours
Job Summary:
Responsible for the identification, analysis, and prevention of quality issues. Provides advice and support to Operations staff in the implementation of, and adherence to, processes, controlled documents, tools, and templates to enhance the quality of deliverables reporting to the Director of Quality Assurance. Focusing on continuous improvement and ensuring adherence to agency regulations, GXP, Industry Guidelines, local regulations, along with Spaulding Clinical policies and procedures for the conduct of clinical trials through reporting of data. Works closely with Clinical and Biometrics, along with other supporting teams, to help ensure active participation in continuous quality improvement activities.
Essential Duties and Responsibilities:
Must know, facilitate, and maintain GCP/ICH compliant processes which control the quality of work and clinical trials conducted at Spaulding Clinical.
Assist with activities in the areas of CAPA (Corrective and Preventive Actions) and Training support.
Work closely with clinical and biometrics managers and training coordinators to implement solutions to ensure repeatable procedures in operations.
Lead Clinical auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, process improvement activities).
Lead or assist with identifying non-conformances with requirements and provide suitable recommendations for maintaining compliance with applicable study protocols, Quality System Regulations and/or ISO standards where applicable.
Participate in SOP and process development or consultation as assigned.
Maintain an understanding of Spaulding Clinical?s standard operating procedures and of relevant regulations and guidelines.
Assist in conducting supplier audits and work with suppliers in eliminating problems to ensure that study quality continuously improves.
Work closely and collaboratively with other Management within and outside of Operations and Biometrics.
Assess Role based training matrix, modify, and submit changes as needed
Develop, track and report on quality metrics in operations. Support special projects requiring QA input.
Who We Are:
SPAULDING CLINICAL aims to be the clinical research organization by which all others are measured. Pioneering in our approach to redefining how the industry perceives and achieves success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for our volunteers, customers and employees; and heroic in our ambitions to ensure the health and safety of people around the globe - Spaulding Clinical is taking research beyond results to create a marketplace of safer drugs. Here at Spaulding, our employees are not cogs in a wheel or dollar signs on a spreadsheet. They are the innovators and designers behind the life changing ingenious solutions and disruptive innovations that ensure we are ready to face that next great challenge. We never know when the next study we might conduct could be a cure for cancer or HIV, so come be disruptive with us!
Job Type: Full-time
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