Clinical Research Assistant

Description

Position Summary

The Clinical Research Assistant will provide direct support to the research program at Associated Eye Care. This position works closely with the providers, technicians, and research groups to provide clinical trial organization and support.

Clinical Research Assistant Essential Functions

• Assisting with study initiation activities, such as coordinating the delivery of study-related paperwork, equipment, demos, supplies, and participating in study-initiation meetings.
• Overseeing and participating in patient recruitment, screening, scheduling, and informed consent activities.
• Serving as the primary patient contact in areas such as counseling the patient on visit requirements, study purpose, and study costs, etc. and providing high quality patient care by promptly addressing patient information needs.
• Preparing patient charts for patient visits, ensuring complete data collection, and assisting clinical research technicians with case report form completion as requested.
• Assisting in monitoring visits with sponsor staff (e.g., queries, source document reconciliation, preparing regulatory documents, answering questions)
• Ensuring protocol and regulatory compliance to assigned clinical study protocols.
• Serving as the primary liaison between clinical study sponsors, patients, and AEC staff regarding study protocol requirements and communicates clinical study information with study participants, physicians, clinical study project team, and clinical research manager in an appropriate format (e.g., meeting minutes, status reports, telephone calls, e-mails, memos, and letters).
• Maintaining study regulatory file and test article accountability per internal standards.
• Maintaining accurate clinical study electronic and hard copy documentation in accordance with clinical study protocols, applicable regulations, and departmental procedures.
• Assisting with report preparation and clinical study communications to external agencies (e.g., FDA, IRB) as requested.
• Representing clinical research department on internal project teams as requested.
• Ability to flex hours based on study volumes.

Other Essential Functions

• Must be willing and able to work a variety of hours and work in the various locations as needed.
• Must be available to work outside of regular working hours on occasion and able to travel to other AEC offices as needed

• Must present self at the workstation, ready for work, at the scheduled time
• Participates in department and company meetings, as requested
• Other Duties as assigned

Qualifications

Education & Licensing

• Bachelors Degree in business or healthcare required

Experience

• 1-2 years experience in academic, ophthalmology, pharmaceutical, or medical device clinical trials required.
• 1 year working knowledge of research methodology and federal regulations applicable to clinical trials required

Comprehensive Benefits Package

• Health insurance (free premium plan option for employee only coverage)
• Dental insurance
• Employer paid life and accidental death and dismemberment benefit
• Employee assistance program (EAP) benefit
• Company matched 401(k) plan
• Flex spending accounts (medical and dependent care)
• Health Savings Account
• Voluntary Benefits and Life Insurance Coverage
• PTO Accrual begins on Date of Hire
• Floating Holiday Day
• Annual Scrubs allowance for clinic employees
• Free annual eye exams for you and your immediate family
• Significant discounts on our services and products for employee and immediate family members

Job Type: Full-time

Associated Eye Care is an Equal Opportunity/Affirmative Action Employer