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 approximately eight 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.  

HOURS: Traditional daytime hours.

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.  

• Minimum of 10 years in clinical research experience is required, with emphasis on prospective, randomized Phase 2-4 trials, investigator-initiated proposals and  team development and management. 

• Proven ability to manage multiple projects and tasks and adhere to requested timelines. 

• Recent experience in a clinical patient care setting with demonstrated proficiency in medical terminology and EMR navigation required. 

• Certification with Association of Clinical Research Professionals (ACRP) or CRPC (Clinical Research Professional Certification) with Society of Clinical Research Association (SOCRA) preferred. 

• Additional certifications and/or trainings in program management, leadership, etc. are preferred. 

WHAT YOU WILL DO: 

• Meets Health System's Guiding Behaviors and Caring Standards including interpersonal communication and professional conduct expectations.   

• Facilitates and supports the clinical teams when conducting feasibility assessments, giving insight and feedback related to various operational aspects, including consideration of other supportive  service line needs.  

• Contributes to the Research Executive Committee meetings as needed to provide detailed information regarding potential clinical trials. 

• Supervises the start-up study process for each clinical research team to ensure timely implementation of trial.  

• Manage trial implementation barriers and collaborate with the Director, HRPP to ensure resolution. 

• Maintains a working knowledge of applicable Federal, State, and local laws and regulations, Trinity Health’s Organizational Integrity Program, Standards of Conduct, as well as other policies and procedures to ensure adherence in a manner that reflects honest, ethical, and professional behavior.                            

• Supervises the clinical teams to ensure adherence to departmental guidelines and expectations that ensure compliance with research billing review practices. 

• Supports and mentors clinical research coordinator staff in the following study related activities: 

• Feasibility assessments 

• Submission to Research Executive Committee 

• IRB submissions 

• Maintenance of IRB documentation 

• Consent form development, inclusive of vulnerable population, legal and ethical and religious directive considerations. 

• Completion of study start up activities 

• Management of enrolled study participants. 

• Identification and verification of source documentation. 

• Coordination of vendor and/or sponsor visits 

• Facilitation of training requirements for the protocol specific research team. 

• Completion of activities related to protocol amendments. 

• Identification and management of reportable information 

• Use of EMR and activities to support clinical research role. 

• Lead and/or participate in weekly team meetings. 

• Collaborate with the Director, HRPP, to develop educational sessions for staff to ensure awareness of new guidance or changes to regulations, and reiteration of content where additional learning is an identified need. 

• In collaboration with the Director, HRPP, facilitates legal submissions and supports review of research agreements. 

• Maintains cooperative relationships with partnering surgical, medical, radiology, and pathology departments as well as other disciplines and team members. 

• Maintains a system for organizing, planning, and managing clinical research staff. 

• Performs clinical research quality assurance activities, identifies performance gaps, develops actions plans and mentor staff to ensure comprehension.  

• Collaborate with the EPIC TC team to ensure order sets are developed prior to study implementation and as applicable, for clinical trials involving administration of an investigational product. 

• Participates in monitoring visits and audits of clinical research activities to identify gaps in staff education and training or relevant departmental workflows and SOPs.  

• Ensure staff have provided  timely response to audit findings and other queries. 

• Provides support to clinical teams and collaborates with Director, HRPP to ensure complete resolution of audit and/or monitoring findings. 

• Ability to work independently, balances multiple projects, and meets deadlines. 

• Strong sense of teamwork and eager to assist with unique projects and interdepartmental needs when appropriate.   

• Demonstrate analytical thinking, problem solving and interpersonal skills. 

• Experience using MS Word and Excel, MS Teams and Outlook and EPIC