SUMMARY: 

 Under the general direction of the Director, Human Research Protection Program (HRPP), the Clinical Research Operations Manager supports the day-to-day operations of the clinical research staff and facilitates the identification and implementation of potential clinical trials and other research activities within the Saint Alphonsus Health System. Will act as a liaison between the clinical research teams and Director, HRPP  to ensure regulatory and institutional compliance as well as the preservation of human subject protections throughout the continuum of the research. Will participate in a variety of complex activities involving staff recruitment and training, staff development,  team member performance activities, clinical trial budget negotiation, SOP maintenance, and leadership representation for external vendors, CROs and trial sponsors. 

Will assume responsibility for all daily clinic trial operations and the management of clinical research staff. Additionally, exceptional administrative, project management, leadership and communication skills to develop and maintain academic and industry partnerships. Supports and maintains a positive  working environment and sets an expectation for adherence to the Trinity Health Core Values.  

The Clinical Research Operations Manager serves as the primary clinical research contact in the region for internal and external parties. Functions as a mentor, trainer, and supporter to new and existing research coordinators.  Serves as a coach and a consultant to less experienced employees. Oversees the training of newly hired research staff. Supports Director, HRPP in staff recruitment and retention.  

REQUIREMENTS:  

• Must possess knowledge normally acquired through completion of a Bachelor’s degree in nursing, biology or health sciences or equivalent combination of education and experience.  

• Must possess a comprehensive knowledge of clinical research process and procedure, Good Clinical Practice guidelines and Federal research regulations as well as institutional policy. 

• Minimum of 10 years in clinical research experience is required, with emphasis on prospective, randomized Phase 2-4 trials,