Michele Galvez

• Extract clinical data and research data from electronic medical records and other sources and enter data in the appropriate electronic data capture system.
• Maintain study binders and filings according to protocol requirements and department policy.
• Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
• Assure all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
• Conduct quality assurance of study databases, including double-data entry and validation checks.
• Collaborate with clinical operations teams to identify data issues and resolve discrepancies.
• Review case report forms for accuracy, completeness, consistency, coding accuracy, and adherence to protocol requirements.
• Respond and Resolve data queries.
• Schedule and meet with study monitors and assure patient cases are ready for each monitor visit and DSMC review.
• Participate PI investigator oversight and site disease group [SDG] meetings, site initiation visits [SIV] and routine monitoring visits [RMV].
• Adhere to standards in areas involving data collection, research protocols and regulatory reporting.
• Maintain a secure environment for confidential patient information according to HIPAA guidelines.

• Served as travel Medical Technologist at satellite Medical Center Ocean Reef [MCOR] in Key Largo, FL.
• Conducted diagnostic testing such as tonometry, corneal thickness, visual fields, fundus photography and optical coherence tomography.
• Verified patient medical history records, collected ocular health data, and entered information into Epic/Kaleidoscope electronic health record system.
• Operated equipment used in the practice such as retinoscope, phoropter and autorefractor and keratometer.
• Calibrated ophthalmologic equipment and ensured that all instruments were properly sterilized before use in accordance with OSHA standards.
• Performed detailed eye examinations, including visual acuity testing, refraction/retinoscope measurements and slit lamp biomicroscopy procedures.
• Assisted in surgical pre/post preparations and procedures such as intravitreal ocular injections.
• Collaborated with other healthcare professionals such as optometrists and nurses to provide comprehensive care for patients.
• Developed strong relationships with referring physicians to ensure quality of care for their patients.
• Participated in continuing education courses on new technologies related to ophthalmology.
• Demonstrated excellent customer service skills when interacting with patients and colleagues.

• Directed and supervised team of 100+ employees in daily operations.
• Developed and implemented operational policies and procedures to ensure efficiency and accuracy of workflows.
• Maintained accurate records of employee performance, attendance, leave requests, and disciplinary actions.
• Tracked progress on projects and provided timely feedback to staff members.
• Resolved customer complaints in a timely manner while ensuring customer satisfaction.
• Conducted weekly meetings with team members to discuss upcoming tasks and project deadlines.
• Recruited, hired, trained, mentored, coached, evaluated, and terminated staff as necessary.
• Ensured compliance with workplace safety regulations by providing training sessions for all staff members.
• Monitored employee productivity levels on a regular basis to identify areas of improvement.
• Evaluated employee performance through periodic reviews and documented results accordingly.
• Collaborated with other departments to coordinate workflow processes between teams.
• Coordinated employee schedules according to shift changes and availability.
• Maintained operating schedules to provide effective coverage for key areas and achieve objectives.

• Modeled leadership to team members by addressing concerns, troubleshooting and solving clinical issues.
• Trained current and new employees how to navigate and accurately document Epic/Kaleidoscope EMR system.
• Assisted Informatics team with UChart EMR upgrades and training.
• Conducted research to develop evidence-based instructional content that led to the curriculum design and development of the learning products for BPEI's Ophthalmic Technician Training Program.
• Participated in Best Practices committee to ensure consistent, evidence-based ophthalmic clinicians' exam.

• Assisted in the diagnostic evaluation, treatment, education and care of patients with medical and surgical conditions that affect the visual system using evidence-based practices.
• Learned and followed research study protocols while performing visual and ocular examinations in multiple national/international research studies.
• Served as a department preceptor, trained and supervised new hires.

Casual worker for Joseph Berger M.D.'s " Neurological Complications of HIV" study:

• Utilized specialized software applications related to the job role.
• Maintained confidentiality of sensitive information entered into the system.
• Reviewed existing information for accuracy and made necessary corrections.
• Performed data entry from paper documents, emails, and other sources into computer systems.
• Checked source documents against entered data to ensure accuracy.
• Transported serum specimens to medical campus laboratory.