Position Title: Research Fellow
Salary: Self-funded

Full time (Hybrid) Voluntary (must be self-funded).  Support research activities conducted at Doheny Eye Institute.  Provide general assistance to support research activities. Conduct research experiments in accordance with Standard Operating Procedures (SOP) and Institutional Review Board (IRB) protocols. Perform assignments that are non-routine and vary in complexity with general direction.  Compiles data and computes results for a variety of research procedures, tests and techniques. M.D. or Ph.D. required with 1 – 3 years research experience in related field or specialty.

To Apply: Please complete the Research Fellowship Application form and submit to .

Position Summary: Lead projects centered on the development of innovative adaptive optics retinal imaging technologies aimed at enhancing the study of higher-order retinal hemodynamics in the human eye.

Principal duties:

• Optical System Design: Design a new generation of high-speed, high-resolution adaptive optics scanning ophthalmoscope for imaging retinal blood flow in the living human eye.
• Adaptive Optics Development: Develop novel adaptive optics systems to achieve (near) diffraction-limited imaging performance in the living human eye.
• Instrument Assembly: Assemble and integrate optical, mechanical, and electrical/electronic components to construct a clinically deployable imaging system.
• Project Leadership: Lead the project team to achieve key milestones and deliverables within project timelines.
• Scholarly Publication: Document and publish engineering and scientific achievements in peer-reviewed journals.

Qualifications:

• Educational Background: PhD in Optical Engineering, or Electrical Engineering, or Vision Science, or a related field.
• Optical System Design: Demonstrated experience using optical design software (e.g., Zemax) to design and optimize optical imaging system.
• Instrumentation: Practical skills in aligning, assembling, calibrating, and maintaining optical instruments, demonstrating a capacity to handle complex optical systems effectively from conceptualization through to operational deployment.

Desired Skills:

• Experience in adaptive optics, scanning laser ophthalmoscopy/microscopy, or optical coherence tomography, microscopy.
• Strong background in the control of optical and electronic devices, including experience with scanning systems, cameras, and frame grabbers.

Application: Interested candidates should submit a statement of interest, a detailed curriculum vitae, and contact information for two to three references via email to Dr. Yuhua Zhang at . Review of applications will continue until the positions are filled.

Position Title: Research Fellow – Software Engineering
Salary Range: $61,008 – $74,088/year for MD, PhD, inclusive of comprehensive benefits. This range may differ based on education and experience. 

Position Summary: Lead projects centered on the development of innovative adaptive optics retinal imaging technologies aimed at enhancing the study of higher-order retinal hemodynamics in the human eye.

Principal duties:

• Software Development: Develop software for controlling adaptive optics and the imaging system, including real-time image acquisition.
• Project Leadership: Lead the project team to achieve key milestones and deliverables within project timelines.
• Scholarly Publication: Document and publish engineering and scientific achievements in peer-reviewed journals.

Qualifications:

• Educational Background: BS, MS, or PhD in Computer Science, Vision Science, or a related field.
• Programming: Proficiency in programming, and experience in Microsoft Visual Studio C++ for real-time instrument (camera, data acquisition) control is highly desirable.

Desired Skills:

• Strong background in the control of optical and electronic devices, including experience with scanning systems, cameras, and frame grabbers.
• Sound knowledge of analog/digital circuits or field-programmable gate arrays (FPGA) for instrument control and data/image acquisition.

Application: Interested candidates should submit a statement of interest, a detailed curriculum vitae, and contact information for two to three references via email to Dr. Yuhua Zhang at . Review of applications will continue until the positions are filled.

Position Summary: Quality Assurance (QA) Manager at DIRC is responsible for ensuring the highest quality output for the center while maintaining compliance with all laws, regulations and contractual obligations that apply to the DIRC, and especially the FDA regulations contained in Title 21 part 11 and ICH GCP.

The QA Manager’s job is to implement the Quality Assurance and compliance functions at the DIRC. Additionally, this position is responsible for ensuring that appropriate velocity can be maintained to meet client needs, exceptional quality is in place and regulatory compliance is met.

Principal duties:

• • Oversees DIRC’s quality assurance and regulatory compliance strategy and activities (Percent of time: 50%):
    • Remain up to date with the latest developments in quality assurance and regulatory compliance, as it relates to the DIRC.
    • Maintains an expert level understanding of all laws, regulations and contractual obligations that apply to the DIRC and ensures compliance.
    • Manage external audits and/or inspections by clients, sponsors and/or agencies.
    • Responsible for related inspection readiness activities.
    • Prepare responses to external audit observations and works with impacted stakeholders to address audit findings and in accordance with internal procedures/policies.
    • Provide guidance on procedures, standards, and their interpretation. Provide guidance on proper implementation and proper documentation to department personnel, other DIRC staff, and/or clients.
  • Establish, implement, and manage the following programs:
    • Change and Document Management programs.
    • Competency and Training programs.
    • Non-conformance (NC) and corrective action preventative action (CAPA) programs
    • Audit programs (Internal, External, and Supplier)
    • Management review program
    • Risk management program
    • Development of metrics
  • Serves as Process Owner (and subject matter expert) for related procedures (Percent of time: 20%):
    • Responsible for development, maintenance, and implementation of procedures, including but not limited to:
      • SOPs
      • Work Instructions
      • Forms
      • Templates
      • QA and compliance programs
      • Good Documentation Practices (GDP)
      • Protected Health Information
      • General Data Protection Regulation (GDPR)
      • Provide support for System Development Lifecycle (SDLC) program related to custom software development projects and Commercial Off-The-Shelf Software (COTS).
    • Serve as SmartSolve Administrator (Percent of time: 10%):
      • Provide support for DEI and DIRC related to the administration and configuration of SmartSolve modules, including but not limited to:
        • Audit management
        • Change management
        • Corrective action preventative action management
        • Document management
        • Non-conformance management
        • Training management
        • User Management in conjunction with ITS
        • Sharepoint server management related to SS in conjunction with ITS
        • Software upgrades and module implementation in conjunction with DIRC development and ITS
        • Troubleshooting and reporting of issues/bugs in conjunction with ITS
      • Act as Data Protection Officer (DPO) for DIRC required by General Data Protection Regulation (GDPR) (Percent of time: 10%):
        • Advise and inform DEI/DIRC of applicable legislation and standards, advise on risk assessments, and complete Data Protection Impact Assessments (DPIAs).
        • Handle questions and comments related to personal data, GDPR, and how data is being processed.
        • Advise the organization and employees of the GDPR obligations along with any other relevant data protection provisions relevant to applicable EU member state.
        • To continually track and monitor GDPR compliance for the organization, implement training for employees about compliance and perform GDPR audits.
        • To implement and perform data protection impact assessments.
        • To fully cooperate and communicate with the data protection supervisory authority.
        • To be the focal point for the authority on any matters relating to GDPR, personal data and any other appropriate matters.
      Supervises the quality assurance team, including but not limited to: (percentage of time: 10%)
      • Responsible for staffing, scheduling, interviewing, and hiring, evaluating work performance, counseling, discipline, and termination. Participates in addressing employee grievances.
      • Provides daily direction, communication, training, and oversight to the team to ensure efficient productivity.
      • Monitors and negotiates the scope of work and commitments.
      • Oversee study assignments and resourcing in conjunction with appropriate stakeholders.
      • Aids in the development of training programs for existing staff and new hires.
      • Mentors team personnel, including but not limited to:
        • Establishing timelines/expectations for training of individuals, and monitoring progress.
        • Identifying training and learning opportunities (e.g. technical training, educational programs, quality improvement projects), and involving or delegating to direct reports accordingly.
        • Inviting team members to participate in meetings or teleconferences, both internal and external.
        • Providing feedback for circumstances as observed on a day-to-day basis.
        • Including team members in quality improvement and/or other ad hoc projects.
        • Knowledge and information sharing
      Qualifications:
      • Bachelor’s degree required.
      • Professional training in Clinical Trial Operations; FDA Regulations and ICH/GCP Guidelines for clinical research.  Preferred
      • ASQ (CQA) – Certified Quality Auditor Certification Preferred.
      • Combined experience/education as substitute for minimum education.
      • Five (5) years quality assurance experience.
      • Two (2) years previous supervisory experience.
      • Two (2) years’ experience in the administration or coordination of a quality assurance program in clinical research.
      • Strong familiarity with CFR Title 21, ICH GCP, and GDPR
      • Ophthalmology related work experience preferred.
      • Understanding of ophthalmology research and/or imaging technologies.

      To Apply: Please complete the Employment Application and submit to
      Opened as of: September 26, 2024

Salary Range: $20.51 – $23.08/hour; Full-time Monday – Friday (Remote)

Position Summary: Support DIRC clinical study contracts and general operations by providing a broad range of study support to the DIRC operational teams. This position requires strong attention to detail and the ability to follow through on a large number of details on an ongoing basis.

Principal duties:

• Responsible for the review and processing of images submitted from clinical sites.
• Interacts directly with the clinical sites to identify and resolve problems related to a site’s imaging or submissions.
• In collaboration with the Ophthalmic Imaging Manager and Project Managers, provides feedback on materials, including but not limited to: (ie. Site Instruction Manuals, Project-Specific Manual of Procedures, Qualification, Certification, Image Quality Review and Accessioning Forms.
• As needed, attend sponsor calls and/or investigator meetings. 
• Train and assist other DIRC staff in the imaging and image review procedures for assigned studies.
• Provides project support as assigned.

Qualifications:

• High School or GED required.
• Bachelor’s Degree preferred.
• 2-3 years of progressively responsible work experience, preferably in a research or medical setting.
• Past experience in ophthalmic photography preferred
• Certified Retinal Angiographer (CRA) preferred
• Past experience in multi-center clinical trials preferred

To Apply: Please complete the Employment Application and submit to
Opened as of: September 20, 2024

Salary Range: $25.64 – $28.21/hour; Full-time Monday – Friday

Position Summary: This role includes managing the creation and management SOPs, training materials, and study-specific documents, as well as handling PDs, NCs, and CCs in SmartSolve. The Process Owner will also develop dynamic forms for studies and support various research activities aligned with DIRC’s objectives. In collaboration with the ODE Manager, this role will assist in managing team timesheets, generating metric reports, and scheduling meetings. Additionally, this role will maintain certification, conduct evaluations, and adhering to grading protocols.

Principal duties:

• Serves as Process Owner relating to the following activities, including but not limited to documentation management related to ODE functions, SOPs and related work instructions and forms, training documentation, and study-specific document collaborations.
• In conjunction with ODEM, provides support and assists with ODE team timesheets and shifts.
• Assists with the creation of metric charts and reports.
• Serves as ODE on DIRC projects.

Qualifications:

• High school diploma or GED required.
• Bachelor’s Degree strongly preferred.
• Satisfactory knowledge of the clinical trials process, such as completion of a Clinical Research Associate training course or relevant work experience (serving as a junior ODE in the DIRC satisfies this requirement) preferred.
• Attainment of DIRC Senior ODE status in at least one DIRC Disease Section (implies a high level of competence in image grading in one or more diseases/image types) preferred.
• Strong knowledge of DIRC SOPs relevant to the grading process preferred.

To Apply: Please complete the Employment Application and submit to
Opened as of: September 10, 2024

Salary Range: $20.00 – $21.54/hour; Full-time Monday – Friday (Remote)

Position Summary: Serves as Ocular Disease Evaluator (ODE) on assigned DIRC projects. Evaluates digital ophthalmic images on a computer screen and identifies/characterizes ophthalmic features and pathologies in support of medical research activities.  Completes DIRC’s Evaluator Training program.

Principal duties:

• May perform junior or senior evaluator assessment in any Disease Section for which junior or senior evaluator certification has been attained.
• Maintains up to date knowledge of standard grading protocols, and is highly familiar with study-specific grading protocols for assigned studies
• Maintains up to date knowledge of current grading protocols, and best grading practices as defined by the ODE Manager and Principal Investigator (PI) or Medical Director.
• Understands DIRC proprietary grading software programs and successfully operates them in the conduct of grading activities.
• Checks workload daily and prioritizes cases according to the DIRC Standard Operating Procedures.
• Completes cases in a timely manner to ensure turnaround times are met.
• Adheres to the DIRC SOP in the process of grading, routing of cases, and adjudication.
• Generates reproducible grading answers as measured by the DIRC QA re-grading process.
• Notifies ODE Manager, Project Manager, and PI of any grading protocol deviations.  Immediately reports all potential Significant Medical Findings (SMFs) to the ODE Manager and PI.
• Reviews grading materials prepared by the Project Manager/Study Coordinator and returns materials for resolution as needed.
• Adheres to Good Clinical Practice (GCP) documentation procedures in the recording of study data.  Exhibits a low (<2%) error rate in transcription and all manner of data recording.
• Contributes to the improvement of grading software programs by suggesting changes to improve quality and efficiency.
• Other duties as assigned by the ODE Manager.  May include both project support tasks and general operations support.

Qualifications:

• High School or GED required.
• Bachelor’s Degree preferred.
• 2-3 years of progressively responsible work experience, preferably in a research or medical setting.
• Interest in medical research is a must.
• Knowledge of clinical trials helpful, such as completion of a Clinical Research Associate training course or relevant work experience.
• Interest or experience in photography or the visual arts is a plus.

To Apply: Please complete the Employment Application and submit to
Opened as of: August 6, 2024

Salary Range: $20.51 – $21.54/hour; Full-time Monday – Friday (Remote)

Position Summary: Provides Quality Control (QC) responsibilities for DIRC. Follows and maintains current knowledge of departmental policies and procedures.

Principal duties:

• Perform QC review of source documents for completeness, consistency, and adherence to internal and external policies on Good Clinical Practice (GCP), Good documentation Practices (GDP).
• Coordinate closely with individual staff members and groups to communicate negative findings / errors derived from processing of cases, and educate staff on proper procedure.
• Under the general supervision of the Quality Assurance Manager, assist with audit preparation, in organizing personnel training records, and other documentation to ensure their accuracy and completeness.
• Perform other tasks as assigned to support the quality assurance efforts within the DIRC.   
• Other duties as assigned by the Quality Assurance Manager. May include both project support tasks and general operations support.

Qualifications:

• High School or GED required.
• AA or Bachelor’s Degree preferred.
• Experience working in a clinical research environment preferred.
• Previous experience in a quality control function is preferred.

To Apply: Please complete the Employment Application and submit to
Opened as of: August 6, 2024

Salary Range: $17.50 –  $18.50/hour; Full-time Monday – Friday
Position Summary: Provide housekeeping services to Doheny Eye Institute.

Principal duties:

• Perform day-to-day housekeeping functions as assigned to ensure that the facility is maintained in a clean, safe, and comfortable manner.
• Clean/polish furnishings, fixtures, ledges, etc.
• Clean and sanitize restroom fixtures, hardware, partitions, floors, etc.
• Clean windows/mirrors in the restrooms and entrance/exit ways.
• Clean floors, to include sweeping, dusting, damp/wet mopping, stripping, waxing, and buffing as scheduled.
• Clean walls and ceilings by washing, wiping, dusting, spot cleaning, etc.
• Clean hallways, stairways, and elevators.
• Care for and clean the grounds as scheduled.
• Discard waste/trash into proper containers and reline trash receptacles.
• Assure that work/assignment areas are clean and that equipment, tools, supplies, etc. are properly stored at all times, as well as before leaving such areas for breaks, meal times and end of the work day.
• Relieve, assist, or fill in temporarily on other jobs as assigned by the supervisor.
• Set up tables, chairs, and meeting rooms as directed.
• Assure that assigned work areas are maintained in a clean, safe, comfortable, and attractive manner.
• Report any damage or unsafe conditions to facility property as directed.
• Keep work/assignment areas free of hazardous objects such as protruding map/broom handles, unnecessary equipment, supplies, etc.
• Assure that equipment is cleaned and properly stored at the end of the shift.
• Keep supervisor informed of supply needs.
• Performs special projects or other related work as required or assigned.

Qualifications:

• High School or GED required.
• Six months of experience preferred.
• Must possess the ability to make independent decisions, to follow instructions, and to accept constructive criticism.
• Be able to Sit, stand, bend, lift, and move intermittently throughout the workday.
• Is subject to frequent interruptions and may need to reschedule cleaning activities.
• Must be able to lift, push, pull, and move equipment, supplies, etc.

To Apply: Please complete the Employment Application and submit to