CRC Manager

Management of multiple staff within the Casey Reading Center (CRC) with approximately 12 direct reports, the coordination of projects with this staff, faculty at Casey Eye Institute, and external collaborators, and meeting regularly with the CRC Director and Department leadership for strategic and tactical actions. The appointee shall provide services as assigned by the Director in furtherance of the universitys missions and goals of teaching, research, patient care, outreach and public service.

Personnel Management/Retention

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  • Conduct quality analyses of data inputs and resulting analyses. Manage data analysis on a bi-annual basis (including locks, freezes) within the CRC to check for all items submitted and correct notes in exports.
  
  
  
  
  
  
  
  • Reviewing and updating Data Transfer Agreements (DTA) to ensure the transparent and understandable data acquisition process.
  
  
  
  
  
  
  
  • Oversee work turn-around times for data to be Quality Controlled (QC) and analyzed. Responsibility for direct oversight of quality controllers and readers.
  
  
  
  
  
  
  
  • Utilizing expertise in opthamological testing to confirm that QC personnel in department only make comments that are useful for statistician or analysis review.
  
  
  
  
  
  
  
  • Responsibility for quality assurance in weekly and monthly compliance communications that are sent to sites and the coordinating center
  
  
  
  
  
  
  
  • Oversee and confirm accurateness of billing and invoices with CRC staff assigned to each trial. Verification of completeness of CRC tasks completed by assigned individuals prior to invoicing by CEI Finance Manager.
  
  
  
  
  
  
  
  • Manage pre-trial and post-trial support and execution to ensure adherence to budget, schedule, and scope
  
  
  
  
  
  
  
  • Oversee Manual of Procedures development/management and staff performing this task by monitoring and tracking project milestones and deliverables.
  
  
  
  
  
  
  
  • Assist staff in time management between projects and research activities, confer with CRC personnel to identify and resolve problems.
  
  
  
  
  
  
  
  • Project management for timelines related to contracted work and developing detailed project plans.
  
  
  
  
  
  
  
  • Efficiency identification
  
  
  • Create and manage training documentation for personnel by providing manuals and web-interface support
  
  
  
  

Sponsor Related Activities

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  • Oversee clinical site interaction for web interface training, certifications, suboptimal images, and required uploads forstudy consultation on clinical trial design and endpoint determination for each of the modalities that are offered, trial certification, assessment of anatomical and functional clinical trial endpoints
  
  
  
  
  
  
  
  • Build scope for requested data freezes and locks with industry sponsors. and manage processing of these within the CRC.
  
  
  
  
  
  
  
  • Oversee customer interactions via the phone and email
  
  
  
  
  
  
  
  • Administer quality checks on site submissions by reviewing that the written procedures have been, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit
  
  
  
  
  
  
  
  • Responsible for correcting outstanding issues with site submissions to the CRC.
  
  
  
  
  
  
  
  • Supervise communications to clinical sites regarding compliance issues
  
  
  
  
  
  
  
  • Directing, drafting and issuing of memos/communications to sites
  
  
  
  
  
  
  
  • Organize review of site performance stats to Sponsors as requested
  
  
  
  
  
  
  
  • Manage staff performing certifications for clinical site staff and equipment
  
  
  
  

Contracting

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  • Complete Requests for Proposal with team and develop procedures for data management, evaluating new data quality and prepare for new data analysis.
  
  
  
  
  
  
  
  • Contracts-
    
    
    
    • Present data to Director to provide project summaries and troubleshoot to analyze data and resolve operational problems
    
    
    
    
  
  
  
  


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    • Work with Tech Transfer to finalize contracts for clinical trials and research projects
    
    
    
    
    
    
    
    • Monitor varying contract timelines
    
    
    
    
    
    
    
    • Create scope of work for contractual agreements with team
    
    
    
    
  
  
  • Collaborate with Finance Manger on reading center budgets for both Sponsor proposed projects and grants.
  
  
  
  

Regulatory Agency Compliance and Quality Assurance Oversight

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  • Oversee regulatory agency audits (Information Systems, Investigative and Operational type audits) of the CRC
  
  
  
  
  
  
  
  • Oversee Standard Operation Procedures (SOP) development
    
    
    
    • Administer tracking and completion of Quality Assurance Issues and CAPA
      
      
      
      • Direct documentation of internal processes with regard to clinical trial design and endpoint determination for each of the modalities that are offered; trial certification, and assessment of anatomical and functional clinical trial endpoints.
      
      
      
      
    
    
    
    
  
  
  
  


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    • Development of new SOPs as needed for the CRC
    
    
    
    
    
    
    
    • Updating SOPs as needed to reflect any reading center policy changes
    
    
    
    
    
    
    
    • Maintaining SOPs on Bridge site
    
    
    
    
    
    
    
    • Initiating and completing annual review of SOPs and maintaining FDA-compliance with regard to standard operating procedures and quality assurance
    
    
    
    
  
  
  • Supervise workflow management and documentation
  
  
  
  

Bachelors degree, Demonstrate strong leadership skills, interpersonal skills, and administrative responsibilities.

3 years of relevant experience in supervision/management.

3-5 years of relevant experience in administration.

Experience in contractual agreements, budget development and maintenance. Strong preference will be given to applicants with experience with industry sponsors, FDA regulations and other regulatory bodies. Proficiency with Microsoft Word, Excel, Visio, Adobe Acrobat Pro, electronic document systems, xml and database programs preferred. Proven ability to learn new software to perform job related functions, customer-service experience, and detail-orientated image analysis experience.

Basic computer keyboarding skills (typing speed >40wpm). Working knowledge of medical terminology. Strong relationship building and interpersonal skills - able to resolve conflicts and to problem solve between parties. Demonstrated evidence of strong written and verbal communication skills. Ability to manage competing priorities. Ability to meet deadlines and urgent system needs. Ability to work independently; willingness to serve as a positive and professional role model. Must have demonstrated record of reliable attendance, punctuality and proven successful performance in past and present.

Masters of Business Administration or higher in the related field.

Significant management experience.

Demonstrate strong leadership skills, interpersonal skills, and administrative responsibilities.

Working Conditions:

Must be able to sit or stand for long periods, indoors, during regular working hours.

Physical Demands & Equipment Usage:

• Periods of continuous sitting and standing throughout the day


• Repetitive finger, hand and wrist motions.


• See differences between colors, shades, and brightness.


• Use stomach and lower back muscles to support the body for long periods without getting tired.


• Focus on one source of visual input and ignore others.


• Make accurate repeated movements of fingers, hands, and wrists.

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