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

• Master’s degree with major courses in relevant field and 3 years of experience; OR Bachelor's Degree in relevant field AND 5 years of clinical research Coordination experience 
• SoCRA or ACRP required within 12 months of hire
• Working knowledge of FDA and other regulatory guidelines (e.g. ICH-GCP E6, HIPAA) that govern clinical research. Ability to translate knowledge into practice and effectively translate that knowledge to others
• Clinical research coordination experience must be comprehensive; covering regulatory, patient interactions, management of safety events, etc.
• Self-starter with ability to work independently but collaboratively as part of a team; capable of establishing and maintaining effective working relationships with a range of individuals from a variety of departments, institutions and organizations
• Ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment
• Proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint
• Excellent communication, analytical and organizational skills, with demonstrated ability to express and document ideas clearly and concisely in both verbal and written communications.
  
  

• Master’s degree, preferably with major courses in relevant field and 3 years of relevant experience
• Experience coordinating clinical research studies, preferably in the field of cardiology
• Experience as a Trainer, Teacher or Instructor in clinical research, or another medical field

Apply here online. Please be sure to upload a cover letter and CV.

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.


As an organization devoted to the health and well-being of people in Oregon and beyond, OHSU requires its employees to be fully vaccinated against COVID-19.