The Knight Cardiovascular Institute (KCVI) at Oregon Health & Science University (OHSU) is seeking a Clinical Research Compliance & Education Specialist to join it's clinical research team.
The Clinical Research Compliance & Education Specialist (TI Clinical Research Associate) will design and train individualized training and onboarding SOPs for new clinical research employees, as well as implementing standardized refresher or retraining for existing employees as necessary.
This role will specifically focus on achieving regulatory compliance, as well as providing standard work information necessary for completion of job duties related to the conduct of clinical research for employees who support cardiovascular-related research (e.g., clinical research assistants, coordinators, team leads, nurses, advanced practice practitioners, etc.).
The Clinical Research Compliance & Education Specialist will recognize and identify gaps in workflows and work closely with the Clinical Research Managers, Trials Administrator, and Clinical Research Medical Director to identify methods and tools to facilitate improvement. In addition to hands-on training, the Clinical Research Education and Compliance Specialist will work closely with the clinical research manager and clinical research medical director to develop group-wide training programs and materials necessary to address key audit findings or to facilitate training of other clinical research topics.
This role will also be responsible for management of all regulatory processes within the trials program at KCVI, including maintaining all regulatory documents, IRB protocols, and training certificates. Lastly, this role will also be responsible for performing internal monitoring and audits to ensure adherence to department SOPs and practices that are in line with FDA regulation and GCP requirements, while also identifying deficiencies.
The Clinical Research Education and Compliance Specialist will collaborate with KCVI Clinical Leaders and the Clinical Research Manager to identify at risk trials and will provide a comprehensive report of findings and action items to address with each study audited. They will also provide support for any external audits (FDA/Sponsor audit) and work with the clinical research manager, team lead, and Clinical Research Medical Director to ensure that any corrective action or response to audit findings are carried out appropriately
Apply here online. Please be sure to upload a cover letter and CV.
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