The UCSD Viterbi Family Department of Ophthalmology and Shiley Eye Institute is a global leader in research investigation in ophthalmology and visual sciences. With the increasing quantity of clinical, imaging, and testing data available in the modern era of electronic health records and digital health, ophthalmology is poised for rapid advancements in artificial intelligence and "big-data" predictive analytics. Our department is growing its research programs in computational and data science to power innovations in this space. This includes analyses of existing data as well as conducting prospective clinical research studies.

Collaborates with physicians and researchers working in clinical research in ophthalmology at UCSD. Responsible for coordinating and managing various clinical trials simultaneously, including providing all aspects of protocol management, including patient recruitment and scheduling, screening for patient eligibility, data acquisition, collection and analysis, interpreting research protocols, ensuring protocol compliance, maintenance of accurate and complete clinical research files, adverse drug reaction reports, monitoring patient treatment and toxicities, performing phlebotomy, collecting and handling laboratory and human specimens, organize samples, enter sample information into database, ordering supplies, disposal of biohazardous waste and miscellaneous laboratory waste. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with superiors, assigned physicians and and other collaborating groups, including attending meetings and providing reports. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing. Provide coordination and general administrative support to research activities in ophthalmology.

• Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.

• BLS/BART training & certification

• Experience performing clinical research duties in a clinical research environment.

• Phlebotomy training, certification, and experience, with demonstrated ability to perform venipuncture/phlebotomy on patients with difficult venous accessibility.

• General knowledge of ophthalmology and visual assessments.

• Certified Phlebotomy Technician I (CPT I) by the State of California at the time of hire or within 6 months of the hire date.

• Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Redcap, Velos, Access, Excel, MS Word and other Microsoft applications, and Shared drives.

• Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

• Experience working with FDA policies regulating clinical trials.

• Experience in medical assessment and patient interviewing, such as to determine toxicities related to protocol management or to determine study eligibility.

• Experience interpreting medical charts, experience in abstracting data from medical records.

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

• Certification/training in Health Insurance Portability and Accountability Act (HIPAA) and the Collaborative Institutional Training Initiative (CITI) Program.

• Knowledge of x-rays, scans, and other diagnostic procedures.

• Experience with clinical trials participant or study subject recruitment.

• Experience coordinating study startup activities.

• Experience providing in-service training to various research personnel on protocols, processes, and procedures.

• Experience maintaining files and keeping records.

• Excellent planning and organizational skills and ability to adapt well and work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.

• Ability to work independently and in a team environment. Ability to maintain confidentiality.

• Experience completing clinical trials and clinical research case report forms via hard copy and online.

• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

• Experience with electronic health records systems (i.e. Epic) and experience in interpreting them to determine participant eligibility and to schedule appointments.

• Ability to use electronic remote meeting applications such as Zoom & Microsoft Teams.

• Excellent ability to have effective working relationships with other employees, students, and faculty to solve problems, improve work processes, share information and resources, and accomplish in a professional and ethical manner.

• This job description is not intended to be all-inclusive. It is understood that all Department of Ophthalmology staff will also perform other reasonably related duties if requested by their supervisor or other leadership personnel. It is customary for staff to assist and support their colleagues during times of peak workload, as appropriate and as approved by supervisors.

• Must be able to obtain annual TB/Fit test clearances.

• Fluency in both English & Spanish (verbally, in writing and reading).

• General knowledge of ophthalmology and visual assessments.

• Certification as a Clinical Research Associate or Coordinator.

• Experience working with research bulk accounts.

• Experience with investigational drug authorization criteria.

• Employment is subject to a criminal background check and pre-employment physical.

• Occasional evenings and weekends may be required.

• Must be able to work various hours and days based on business needs.

• Must be able to obtain annual TB/Fit test clearances.