OHSU Casey Eye Institute is a premier academic medical center providing eye care for adults and children in the Pacific Northwest and beyond. We treat eye conditions from the most straightforward to the most complex, and offer expert care in all ophthalmology specialties.

 

OHSU Casey Eye Institute has one of the top ophthalmic research programs in the country. Our scientists and clinicians have worked together to perform research studies that have revolutionized the practice of ophthalmology, and we continue to explore, innovate, and find new treatments for eye disease. OHSU Casey Eye Institute's faculty are responsible for many of the most recent advances in ophthalmology, which have revolutionized the diagnosis and treatment of many ophthalmic conditions. Advances in optical coherence tomography, ophthalmic informatics, corneal refractive, retina and pediatric eye care have been pioneered at Casey.

 

The TI Senior Clinical Research Assistant will coordinate and supervise study procedures for current and future therapeutic interventional clinical trials conducted in the Ophthalmic Genetics Division, Gene Therapy Center at the Casey Eye Institute. Clinical trial participants include adults and children with inherited retinal degenerations and associated vision loss being studied and developed for new gene therapy treatments.

Develop and maintain participant eligibility and recruiting database for complex therapeutic interventional clinical trials. Identify potential subjects for gene therapy clinical trials through chart review, discussion with investigator or other mechanisms; reviews medical records for eligibility; independently schedules, orders, communicates assessments and appointments; assists with consenting process and ensures accurate completion of appropriate forms and source documentation. Prepare written analysis and reports based on prospective study participants for Principal Investigator (PI) review. Maintain expert knowledge of study-specific details including: study design, study schedule, participant population, cohort-specific eligibility criteria, regulatory requirements, and OHSU patient requirements.

Conduct tests of visual function according to protocol, including best-corrected visual acuity, visual fields, electrophysiology, color vision assessment, reading speed, and others (as specified by study protocol(s)). Obtain and maintain Reading Center certification, as needed.

Monitor and maintain regulatory compliance. Prepare regulatory submissions for IRB, FDA, ICH, and HHS (as required).  Draft regulatory documents and Case Report Forms (CRFs) for new and ongoing studies (informed consent, protocol amendments, recruiting materials, child assents, etc.).

 

Independently manage, collect, and maintain study data including: processing of raw data prior to third-party analysis, complete and submit electronic and paper CRF’s, and document research visits in EMR.

 

Enter medication orders for research products, imaging, laboratory tests, medications, and examinations.  Review patient medical records and document patient visits.  Measure and record vital signs in medical records.  Notify appropriate physician(s) of out-of-range laboratory results.

 

Develop policies/procedures to support group functionality, ensure all internal parties are regularly informed of process revisions and updates.

 

Record and maintain invoicing records and generate regularly scheduled invoices to study sponsors.

 

Compliance expectation: Performs requirements for Staff Members as outlined in Compliance Roles and Responsibilities in OHSU Hospitals and Clinics.  Carry out job responsibilities in an ethical, effective, and professional manner. Report potential compliance problems using the reporting processes as outlined in the Code of Conduct.   Model ethical and appropriate behavior, professional standards, compliance, and personal integrity.  Understand and comply with the Code of Conduct, OHSU and departmental policies and procedures, applicable rules, regulations, etc.  Documents in medical record all patient care services delivered in support of third party bills.  Processes billings for hospital and clinic charges in accordance with HCFA, Medicaid, Champus and all commercial and managed care carriers.  Assures departmental compliance with all applicable third party payer regulations and contracts.  Adheres to all Casey Eye Institute Service Excellence standards and expectations and attends all related mandatory training programs.

 

Schedule and attend study monitor visits. Respond to monitor/sponsor requests for information, make recommended revisions to study documents, and readily communicate regulatory requirements and deadlines to study sponsors and monitors.

Order protocol specified surgical and study supplies. Oversee and attend all required pre- and post-surgical research subject appointments at OHSU clinic locations, when necessary.

This position description may not include all duties of this position and additional duties may be added at the direction of the supervisor, Principal Investigator, and Co-Investigators.

Collect, process, prepare and ship aliquots of biological samples (blood, urine, tears etc)  in accordance with OHSU policy and study-specific manuals of procedure.

 

Present regular written reports and updates to department management and staff at research meetings.

Bachelor's Degree in relevant field AND 1 year of relevant experience OR Associate's AND 3 years of relevant experience OR 4 years of relevant experience OR Equivalent combination of training and experience.

 

BLS certification through American Heart Association (AHA), provider level is required at time of hire. Initial certification is the responsibility of the employee. Renewal certification classes/cost provided by OHSU if job required.

 

Willing to learn how to conduct variety of visual function tests stated above.  Can develop good rapport with visually impaired patients.  Works well with diverse group of individuals in a small space (physicians, trial coordinators, ophthalmic techs, and others).  Strong computer skills (including Microsoft OS and database experience).  Ability to learn web-based databases quickly.  Strong organizational and communication skills.  Ability to prioritize work demands and manage time appropriately.

 

Demonstrated evidence of strong written and verbal communication skills.  Ability to meet deadlines and urgent patient and 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.

 

 

• Degree in Biology, Genetics or related field.
• Previous clinical and/or research experience
• Basic medical experience (vital signs)
• Competence in computer work (both PC and Macintosh), Proficiency in Microsoft Office
• Phlebotomy certification preferred, or willingness to get certified.

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.