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Clinical Research Manager
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Full-time
- The Clinical Research Manager for the Hypertrophic Cardiomyopathy (HCM) and Amyloid Clinical Research Program oversees and manages the day to day operations of clinical research activities conducted within the trials program within Knight Cardiovascular Institute.
- This position is also responsible for day to day operational management of all active trials within the program, this includes management and coordination of all study startup activities, working with the Education/Regulatory Specialist in the program to ensure regulatory requirements are being met, including development of preparatory workflows for potential FDA audit, as tracking enrollment and screening data to ensure enrollment goals are met for each of the studies.
- This requires interfacing with central service teams at OHSU to ensure alignment of procedures with institutional standards.
- Day to day operational issues, and cross-training for back-up coverage in all areas of clinical trials operations - regulatory/IRB, patient assessments and care, sponsor communications, data entry and query resolution.
- Collaborate with HR and the Education /Regulatory Specialist in building a standardized onboarding plan for new staff.
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