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 provides direct management for all research coordinators within the HCM/Amyloid Trials Program. This includes performance management, recruitment, orientation and onboarding of new staff, as well as ensuring that staff are reporting their time accurately and timely for internal billing to the studies.
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. Lastly this position is also responsible for working with the Trials Administrator in developing study budgets, reporting accurate and timely coordinator hours for internal billing processes, and providing required information to the Trials Administrator and finance team for the development of the fiscal year budget for the trials program.
The Clinical Research Manager will also be responsible for working with the Trials Administrator in developing standard processes for the facilitation of clinical trials within the Institute. This requires interfacing with central service teams at OHSU to ensure alignment of procedures with institutional standards.
Master's in relevant field AND 3 years of relevant experience in coordinating clinical trials OR Equivalent combination of Bachelor's in relevant field in conjunction with training and experience may be considered.