Director Clinical Research
- Posted: 29 January 2021
- Tempe, AZ, USA
At American Vision Partners (AVP), we’re bringing the best together. Our company was created with the affiliation of Barnet Dulaney Perkins Eye Center, Southwestern Eye Center, and the M&M Eye Institute. Today we’re one of the nation’s largest and most comprehensive ophthalmology practices with more than 45 eye care centers in Arizona and New Mexico - including 24 ambulatory surgical centers. At AVP we are committed to best in class patient care, being a pioneer in research and technology and most importantly, rewarding and recognizing our employees!
Director of Clinical Research- Tempe, AZ
American Vision Partners
The Director of Clinical Research facilitates and monitors the clinical research process and is a key driver of efficiency by leading process improvement in clinical research start up. This position develops and implements plans and standard operating procedures under the guidance of study/sponsor leadership. Continuously reviews study start up related issues and serves as the initial point of contact to remediate problems and issues as they arise and develop strategies to overcome barriers to trial initiation and completion
- Include Intentionally - Cultivates diverse teams and inclusive workplaces to expand thinking.
- Live the Values - Role models our values with transparency and courage.
- Enable Change - Takes action to drive change and innovation that will transform our business.
- Achieve Results - Takes personal ownership to deliver results. Empowers and trusts others in decision making.
- Develop the Best - Raises the bar with every talent decision and guides the achievement of all employees and patients.
- Monitors study startup for all trials and reduces study start up time through efficient and effective project management. Troubleshoots during the study start phase by identifying process defects and waste and provides a framework for organizational efficiencies.
- Develops clear, precise and detailed metrics reporting on study start up timelines, identifying systematic areas of delay. Responsible for tracking, monitoring and reporting on study start up timelines with a focus on contracting, budgeting metrics and device purchasing timelines.
- Interfaces with various departments and facilities to ensure that approvals for clinical research initiation are obtained with a focus on device trial initiation.
- Serves as a resource and subject matter expert to others for all aspects of initiating complex and multi-site clinical studies to include rapidly emerging device trials. Provides education, training and orientation for new research faculty on research approval process requirements.
- Stays abreast in relevant news or changes related to but not limited to Clinical Research SOP’s, IRB (local and central), CR Budgets and Contracts, etc.
- Ensures efficient management of resources resulting in timely execution of trials and utilizing existing institutional infrastructure where appropriate. Provides oversight and guidance, as needed, to research staff, faculty and leadership to ensure proper progress and initiation of studies.
- Coordinates and communicates study specific issues in site initiation to investigators, sponsors, study coordinators, clinical team, manager and other institutions in a timely fashion with proposed options for real time resolution.
- Builds rapport with clinical research faculty staff and leadership across institutions to facilitate programmatic initiatives and monitor ongoing improvement efficiencies.
- Adheres to all relevant regulations including but not limited to Banner’s compliance offices, Human Subject Protection Program, HIPAA and Conflict of Interest offices to ensure operational, regulatory, and financial success of the combined research programs and shared goals.
- This position is responsible for the sponsor’s daily operations from start-up to completion of clinical trials.
- All Other Duties as Assigned
- BA degree required. RN license a bonus.
- Minimum 3 years of supervisory experience in a Clinical Research Role and Minimum 8 years in Clinical Research.
- Hands on experience with both pharmaceutical and device trials.
- Knowledge of the principles and techniques of clinical research development and modern research methods including data collection, analysis and skills in monitoring study start up process.
- Expert in Clinical Research Budgets and Contract in relation to both Grant and Sponsored trials.
- Experience with leading and coordinating process improvement mechanisms.
- Experience with analyzing and evaluating data and providing summarized reports and visual process analytics.
Benefits & Perks:
Your health, happiness and your future matters! At AVP, we offer everything from medical and dental to significant eye care discounts, continuing education, 401(k), 9 paid holidays plus PTO, flexible work hours and much more!
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.