CEI
Clinical Research Coordinator - Ophthalmology
Blue Ash, Ohio · Staff+
Sponsorship not specifiedDetected 71 days ago
GCPExcelClinical TrialsClinical ResearchResearch
About the role
- Ensures compliance with study review board and monitors.
- EDUCATION AND/OR EXPERIENCE - Position requires at least high school graduate.
- CERTIFICATES, LICENSES, REGISTRATIONS - Position also requires CCRC or higher.
Responsibilities
- Prepare/manage site for clinical research studies, create study-specific source document binders for each subject including appointment calendar for study visits and enrollment logs; prepare for monitor visits including initiation, interim, and close-out visits; create protocols for Investigator Initiated Trials.
- Conduct clinical research as outlined in the study protocol; maintain knowledge of clinical research issues; follow GCP guidelines; implement confidentiality and privacy regulations.
- Complete study source documentation; complete/submit case report forms via courier service, fax, or electronic data capture; dispense/collect study drug/device as outlined in the study protocol; maintain study supplies, study drug/device accountability logs, and calibration logs.
- Assist in classifying and reporting Adverse Events and Serious Adverse Events to sponsor and IRB; manage follow-up care; report relevant events and/or resolution.
Requirements
- Thus, those needing to travel for work must have access to dependable transportation, and driving record must meet company liability carrier standards.
- Must have good working knowledge of Word, Excel and Access.
- Indicate the amount of time spent for each activity required as it relates to the essential functions.
- obtain/maintain study-specific examiner certification as required by protocol for participating study staff
- Maintain regulatory documents including those items required for study site, sponsor, and IRB for initiation, interim reports, and close-out documentation.
- A strong working knowledge of ocular anatomy and common diseases and conditions typically obtained by having at least 1 year of ophthalmic or optometric experience is required.
- Must have at least 1 year of ophthalmic technician experience typically acquired through working in an ophthalmic or optometric office.
Benefits
- Vision peripheral vision
- Vision ability to adjust focus
- Participate in subject recruitment, advertising, patient education/subject consent process, enrollment process, & follow-up visits.
- Perform study-specific testing/exams, administer questionnaires/surveys per protocol guidelines; document medical/ocular health.
Visa & Work Authorization
- Evaluate protocols; assist in study selection; correspond/coordinate with the sponsor/CRO; prepare study budgets
This listing is sourced directly from CEI's careers page and normalized into a canonical job model.