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.

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.
• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

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.
• 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.

• 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.
• 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.

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.

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.
• 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.