Sterile Processing Manager

Sterile Processing Department Training ManagerCertification in Sterile Processing (CRCST, CIS, CHL) 5+ years of experience in clinical research compliance or supporting clinical trials Strong knowledge of regulatory requirements (FDA, AAMI, CDC, Joint Commission) Excellent written/verbal communication and proven collaboration within the clinical research space Experience delivering specialized training materials in an SPD environment Open to significant domestic travel to hospitals - preference would be located in the MidwestAn employer is seeking a Sterile Processing Department (SPD) Training Managers for a long-term contract opportunity. This SPD Training Managers will collaborate with clinical trial coordinators to ensure proper handling of experimental instruments and medical devices, monitor staff competency and adherence to standard and trial-specific sterile processing procedures. They will also be tasked with identifying sterilization-related issues impacting the trial's integrity. The SPD Training Managers will be joining a leader in the Medical Device industry to provide ongoing education for SPD staff regarding trial procedures and communicate SPD status/concerns with clinical research teams. This role can sit remote but will require significant travel to US hospitals to assist in the training of SPD technicians to complete the sterilization and clinical trial studies. Other responsibilities will include developing and implementing training programs for SPD staff tailored to the needs of the clinical trial, maintaining detailed documentation and training records to support regulatory compliance for trial audits, ensuring sterilization protocols align with trial-specific research standards and following safety protocols for compliance within the trial's sterilization practices. While on site the SPD Consultant will provide inventory management, prepare case carts, ensure sign off of sterilization records, ensure receipt of devices delivered mid-trial and report out on devices delivered to Central Sterile from cases and devices included in sterilized trays. They will also oversee the C&S process usability validation support and internal C&S process consultation in addition to reviewing content for IFUs, review guides, wall posters and training material. The selected team members must be comfortable with a flexible schedule, travel weeks will provide 40+ hours of work, while non-travel weeks will require less than 30 hours of work. On average the Training Managers can expect the hourly breakdown to average out to 32 hours a week over the initial 12-month contract. Selected consultants will be required to complete site required credentialing, background, and drug test.