Michelle Ramage

Experienced with clinical trial management, ensuring seamless progression from start to finish. Utilizes strategic planning and regulatory acumen to uphold compliance and project integrity. Track record of fostering effective team collaboration and achieving reliable outcomes.

• CRA professional with more than 20 years of clinical Ophthalmology experience and more than 14 years as a Clinical Research Assistant/BCVA examiner. Active participation in Phase II & III ophthalmology studies with a concentration in diabetic macular edema, Retinal vein occlusion, exudative macular degeneration, Fuchs’s dystrophy, cornea crosslinking for keratoconus and infectious keratitis, as well as dry eye studies. Device trial experience includes implantable artificial iris for aniridia and light adjustable intraocular lens.
• Experience in site identification/feasibility and study start up processes.
• Maintain timely and effective communication among team members and site staff. Anticipates, identifies and resolves issues impacting the study.
• Ensures compliance with local regulations, Code of federal Regulations (CFR), International Conference of Harmonization (ICH) according to essential Regulatory Document Guidelines Trial Master File (TMF) plan. Participates in TMF and on-site audits as requested.
• Responsible for site management and site staff performance.
• Participate in all types of site visits ensuring compliance with protocol requirements, patient identification and recruitment plan is in place, and timely reporting of Adverse Effects (AE’s) / Serious Adverse Effects (SAE’s) and protocol violations.
• Ensures proper storage, and accountability of all Investigational products and trial related materials.
• Reviews the site regulatory binder for accuracy.
• Completes and submits Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms.
• Complete/submit visit reports according to SOP/Work Instructions (WI) requirements. Monitor key study performance indicators such as Telephone Communications Reports, patient enrollment, and SAEs.
• Document and track resolution of all outstanding site-specific protocol-related issues from visit to visit.
• Prepares for and attends Investigator meetings. Assists with the preparation of study start up materials and tools. Participates in clinical monitoring staff meetings, project team meetings, and clinical training sessions according to the project communication, monitoring, and/or training plans.