Anastasiya Johnson

As Clinical Research Coordinator,

• Screen potential patients for protocol eligibility.
• Present trial concepts and details to the patients, participate in the informed consent process, and enroll patients on clinical trials.
• Assist with patient care in compliance with protocol requirements.
• Participate in data collection, entry, and report for the subjects.
• In collaboration with the physician, review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
• Participate in required training and education programs as well as monitoring and auditing activities.
• Participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite.
• Assist with collection and maintenance of regulatory documents in accordance with USOR SOPs and applicable regulations.

As Data Coordinator,

• Under minimal supervision extrapolate data from source records into case report forms for all patient visits.
• Ensure timely data submission in accordance with USOR SOPs.
• Responsible for resolving queries, communicating concerns or questions about data to clinical staff and or research management.
• Coordinate monitoring and auditing visits ensuring that all data and queries are entered and resolved in accordance with the USOR and sponsor requirements.
• Utilize USOR clinical trial management system to access research forms and keep current all applicable patient reporting and tracking functions including the patient billing and research payout and payment tracking.
• Maintain research records in a confidential manner according to practice policies, sponsor confidentiality agreements, HIPAA guidelines and any other applicable regulations.
• Provide leadership in determining and implementing improvements to policies/processes.
• Serve as a resource to train others regarding timely data entry and query resolution, proper conduct of sponsor monitor and audit visits.
• Participate in the training and professional development of other data coordinators.

• Design and conduct hearing research tests and experiments.
• Prepare and analyze samples for Transmission Electron microscope.
• Prepare and analyze samples for Confocal laser scanning microscope.
• Conduct Auditory brainstem response tests.
• Collect and analyze tests and experiments data.
• Scheduling lab meetings, reordering supplies, and maintaining security standards.

• Collect and prepare samples for Confocal laser scanning microscope.
• Prepare and analyze paraffin and frozen sections.
• Perform and analyze data from Optical Coherence Tomography tests.
• Perform Electroretinography tests.
• Prepare and analyze tissue samples imbedded in paraffin, epoxy, or frozen.
• Lab organization and management.

• Gathered, arranged and corrected research data to create representative graphs and charts highlighting results for presentations.
• Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
• Helped team meet regulatory requirements by coordinating documentation and filings.
• Set up equipment, organized inventory and maintained facilities.
• Collaborated with staff to develop and implement best practices and accomplished all team goals.