Clinical Research Manager
- Posted: 08 August 2022
- Phoenix, AZ, USA
Sun City, AZ, USA
Chandler, AZ, USA
Scottsdale, AZ, USA
Mesa, AZ, USA
At American Vision Partners (AVP), we partner with the most respected ophthalmology practices in the country and integrate best-in-class management systems, operational infrastructure, and advanced technology to provide the highest quality patient care possible. Our practices include Barnet Dulaney Perkins Eye Center, Southwestern Eye Center, Retinal Consultants of Arizona, M&M Eye Institute, Abrams Eye Institute, Southwest Eye Institute, Aiello Eye Institute, and Moretsky Cassidy Vision Correction. We are focused on building the nation’s largest and most comprehensive eye care practices and currently operate more than 100 eye care centers in Arizona, New Mexico, and Texas – including 25 ambulatory surgical centers.
At AVP we value teamwork, providing exceptional experiences, continuous improvement, financial strength, and hard work. We are committed to providing best-in-class patient care, pioneering research and technology, and most importantly, rewarding and recognizing our employees!
The Manager of Clinical Research will coordinate the implementation, quality control and completion of research studies while assisting the principal investigator in determining and accomplishing study objectives. Oversees, coaches, and develops the department while driving research studies in an administrative and operational capacity within protocol guidelines.
Barnet Dulaney Perkins Eye Center- Phoenix; travel to all BDP locations
- Works hand in hand with Sponsors to work through Contract, Budget negotiations, and Protocol/Site feasibility.
- Accountable to the ongoing management of study contracts including the billing.
- Assist PI’s in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools to all individuals involved in the study. Documents date of training and signatures of study personnel trained on study specific training log.
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
- Ensures team compliance of SOPs, ICH and GCP guidelines.
- Periodically audits and reviews all study records (consent forms, source documentation, case report forms, etc.), IRB submissions, and drug and device accountability records.
- Order materials and supplies
- Partners with the coordinators to facilitate monitoring and audit visits. Notifies appropriate institutional officials of external audits by IRBs, Regulatory agencies, CROs and sponsors.
- Coordinates with PI and institution to respond to any audit findings and implement-approved recommendations
- Conducts annual performance reviews, determines workloads/assignments, and provides development for department
- Managing investigational product (IP) and reconciliation
- Tracking and reporting on progress of the study including site activation, patient enrollment and monitoring visit
- Provide leadership to direct reports and strategic leadership to division
- Help direct reports overcome any organizational obstacles encountered
- Develop and foster a positive, fulfilling work environment within the division
- Know, understand, implement, follow, and communicate to teammates all AVP employment policies and procedures, awards, and other opportunities within company
- Ensure effective implementation of all corporate programs including but not limited to annual Director and manager bonus process
- Identify and implement methods that enable all division teammates to excel in their assigned roles in a team environment; develop and foster a positive work environment
- Facilitate teammate development (Annual reviews, coaching, mentoring, AVP training, outside training); collaborate with direct reports to create professional development goals
- Review, analyze, and implement staffing plans that promote the most effective use of teammates
- Develop and execute strategic operating plans and goals for assigned division
- Track metrics and success criteria including ROI for all activities
- Analyze current center trends impacting patient service delivery
- Review, analyze, and address gaps in service excellence, policies, and/or procedures proactively; identify issues and implement solutions
- Lead the creation and implementation of teammate development processes and succession planning including mentoring, coaching, and modeling appropriate leadership behaviors
- Participate in on-going training and continuing education
- Support the team and patients by fulfilling additional research related tasks as needed
- BA/BS in Health Science or Related field OR HS Diploma paired with 5 years’ relevant experience
- CCRP (SOCRA or ACRP) required
- Minimum of 6 years Clinical Research Experience
- Minimum 2 years in a lead or management role
- Study Start up to Study completion experience required
- Phase I-IV study experience required
- Budgets and Contracts experience required
- 2 years’ experience with regulatory and IRB function. Direct experience with local and central IRB preferred
- Experience creating, negotiating, and maintaining contract Budgets strongly preferred
- Experience with both Grant and Sponsored Trials highly preferred
- Experience with pharmaceutical AND med device trials highly preferred
Benefits & Perks:
Your health, happiness and your future matters! At AVP, we offer everything medical and dental insurance, significant eye care discounts, child care assistance, pet insurance, continuing education funds, 401(k), paid holidays plus PTO, Sick Time, opportunity for growth, 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. Employment is contingent upon successful completion of drug and background screening. Some positions will require a favorable driving record.