Sara Willis Email & Phone Number

• Support all aspects of site nomination, selection, confirmation, activation, execution, data collection, monitoring, and closure activities.• Develop strong relationships with members of the Clinical Research Team ensuring appropriate sponsor oversight of clinical research centers and trial activities.• Drive the organization of Essential Documents and upkeep of the Trial Master File(s).• Partner with study team to develop and maintain all study documents necessary for trial execution.• Support the review of patient informed consent forms and case report forms as necessary.• Develop Study Newsletters in collaboration with Clinical Program Management and field team members.• Support study invoicing process.• Maintain compliance to all SOP, GCP, and regulatory processes.• Create study-level reporting metrics to support Clinical Program Managers and other team members as assigned.• Good technical knowledge of Inari products and procedures• Good clinical process acumen and ability to drive clinical functional excellence activities.• Drive high quality data collection to support scientific communications, clinical research, and statistical evidence dissemination strategies.• Support Clinical Trial registration at ct.gov as requested.• Support Trial Master File review and audit activities.

Norfolk, Virginia, United States

• Complete study feasibility assessments.• Actively participate in SIV’s and additional training throughout the course of each study.• Assist PI in communication of study requirements to all individuals involved in the study. Document date of training and signatures of study personnel trained on study specific training log.• Work with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.• Conduct or participate in the informed consent process with potential research participants, with focus on the purpose, risk, benefits, alternatives to study participation and answering questions. Obtain appropriate signatures and dates on forms in appropriate places. Assure amended consent forms are appropriately implemented and signed, as necessary.• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.• Register each participant in the clinical trial management system to ensure billing of study procedures to the appropriate funding source.• Maintain effective and ongoing communication with sponsors, research participants, and PI/Sub-I’s during the study.• Coordinate research participant tests, procedures, follow-up visits.• Collect, process, store, and ship blood samples.• Upload imaging to the Core Lab. • Timely Case Report Forms completion and EDC data entry• Report all adverse/serious adverse events to Sponsor in accordance with protocol, update as necessary and report all events to the IRB, as required.• Submit annual continuing review reports to the IRB.• Routinely meet with Study Monitor/CRA during all site visits for inspection of Regulatory documents, Case Report Forms, and study subject’s medical records accuracy and filing.• Maintain adequate inventory of study supplies including Investigational Device/Drug Accountability.• Maintain study files in accordance with Sponsor and IRB requirements

Texas Medical Center, Houston

• Operated as the lead clinic photographer/angiographer at the Texas Medical Center. • Successfully performed diagnostic imaging with Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCT-A), Color Fundus Photography and Angiography, including injection of Fluorescein and Indocyanine Green dyes, to each specification of the 12 physicians. • Captured OCT images in accordance with Clinical Trial protocol as certified photographer.• Thoroughly reviewed diagnostic procedures, including discussions of risks/benefits and side effects. Competently answered questions and obtained signed consent for each diagnostic procedure performed.• Counseled patients on Photodynamic Therapy, calculated and infused Visudyne, and assisted physicians with procedure.• Prepared the Navilas Laser System (1 of 2 in the United States), by capturing a true-color image of the posterior pole, importing a fluorescein angiography image to add relevant pathology, and manually marking blood vessels in order for the Physician to precisely plan and treat targeted areas using navigated laser therapy. • Led photographer training on diagnostic imaging devices.• Set up sterile field with instrumentation, and assisted physicians with B-scan ultrasonography, intraocular injections and minor surgical procedures as needed.Inventoried and purchased all clinical supplies for assigned clinic location

Operated as the only full-time member of a high-volume, multi-location practice dedicated to clinical research, to facilitate start-up and management of industry sponsored clinical trials. Increased the volume of active studies by 10 in less than 2 years, while recruiting and enrolling patients. A direct report to 1 part-time assistant. Negotiated proposed budgets up to 65% • Attended all Investigator meetings to successfully learn each Study Protocol.• Maintained adequate and concise Regulatory and Study Subject records for each clinical trial.• Submitted annual continuing review reports to the IRB.• Negotiated contracts and budgets.• Submitted invoices to the clinical trial Sponsor or CRO for specified contracted procedures, reviewed payments for accuracy and timeliness as specified in the Clinical Trial Agreement.• Recruited and enrolled patients through doctor referrals, Electronic Medical Record review• Conducted Informed Consent with the Principal Investigator and continued effective, ongoing communication with research participants. • Completed Case Report Forms and data entry in Electronic Data Capture systems in a timely manner.• Uploaded OCT, FP, and FA images as specified to Core Lab/Image Reading Centers.• Oversaw collection and shipping of biological specimens to the Central Lab.• Readily met with Study Monitor/CRA during all site visits for inspection of study data, Case Report Forms, and study subject’s medical records.• Lead routine staff clinical trial education meetings.• Conducted weekly Study meetings with Physicians and Practice Administrator.• Successfully organized and hosted educational, clinical research dinner events to present the practice’s current clinical trials to local Optometrists and Ophthalmologists.

Virginia Beach, Virginia

• Liaised with patients and hospitals/surgery centers to ensure timely and accurate distribution of daily surgery schedules.• Coordinated with physicians and surgery centers to ensure equipment and surgical supplies were available and prepared for each surgery.• Consulted patients to review medications and case histories.• Worked with insurance companies to obtain pre-authorization for surgery.• Conducted orientation to explain objectives and procedures to patients.• Prepared and provided pre-operation patient packets by mail. Arranged time, date, and location for patient procedures with primary care physicians; arranged pre-operative medical clearance, testing and/or exams as needed.• Scheduled post-operation appointments and updated chart notes as necessary.

Virginia Beach, Virginia

Study certified Ophthalmic Photographer for clinical trials in a high volume, multi-location Retina practice.• Performed Optical Coherence Tomography, Color Fundus Photography and Angiography, including injection of Fluorescein and Indocyanine Green dyes in a clinic setting and in accordance with all study protocols as the practice’s certified photographer for all Clinical Trials.• Uploaded all imaging to the Core Lab in accordance with each protocol.• Maintained training and compliance with study protocol amendments.• Worked closely with Clinical Research Organizations and Electronic Data Capture Systems in the upload of all study patient images to protocol and responded to queries.• Led photographer training on all diagnostic imaging devices.• Thoroughly reviewed diagnostic procedures, including discussions of risks/benefits and side effects. Competently answered questions and obtained signed consent for each diagnostic procedure performed.• Counseled patients on Photodynamic Therapy, calculated and infused Visudyne, set up PDT laser and assisted physicians with procedure.• Inventoried and purchased all clinical supplies for each clinic location.