Michele Van Rooyen

• Maintained compliance with protocols covering patient care and clinical trial operations.
• Followed informed consent processes and maintained records.
• Gathered, processed, and shipped lab specimens.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Maintained accurate and up-to-date case report forms and source documents for traceability.
• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
• Managed patient recruitment, informed consent process and data entry to support trial objectives.
• Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
• Prepared and maintained regulatory documents for clinical trial submissions.
• Monitored patient safety throughout clinical trials and reported any adverse events.
• Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
• Developed and maintained accurate and up-to-date case report forms and source documents.
• Complied with research protocols by providing ongoing quality control audits.
• Monitored unit budget to meet financial objectives for spend rate and funding.
• Collected, evaluated, and modeled collected data.
• Facilitated focus group sessions with project patients.
• Reviewed referral information and kept track of intakes from various referral sources.
• Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
• Collected data and followed research protocols, operations manuals, and case report form requirements.

Achievements: Slashed costs with 30% by negotiating and building new relationships with the government hospitals and surgeons in Mthatha. Expanded the program into the next district and added another 8 clinics to the program.
Tasks performed.
• Planning and orchestrating scheduling of school visits, clinic visits.
• Managed project of theatre days – transport, food, stock, staff.
• Scrubbed for cataract surgery.
• Maintained schedules for optometry equipment services.
• Wrote accurate reports and budgets based on current information.
• Produced work-related reports on administration and operations for stakeholders and Organized funders visits.
• Adjusted staff levels, work schedules and assignments according to operational requirements.
• I assisted 2 of our workers to complete a course in eye care.

Same as at TASK

• Coordinated and monitored clinical trial activities to support timely and accurate completion of phase I studies.
• Developed and maintained accurate and up-to-date case report forms and source documents.
• Complied with research protocols by providing ongoing quality control audits.
• Monitored unit budget to meet financial objectives for spend rate and funding.

• As Shift leader delegated work to nursing support staff and monitored performance to protect patients and maintain optimal care standards.
• Supported needs of medically complex patients with skilled nursing care.
• Identified patients' current needs through careful observation, vitals monitoring and discussions with loved ones or patients.
• Handled ventilator support, feeding tubes and central lines.
• Coordinated strategies and orders of different disciplines to provide patients' with exceptional care.
• Administered medications and treatments as prescribed by physicians.
• Observed patients' vital signs and administered physician-prescribed medications and treatments.
• Supervised new employees and student nurses to promote adherence to established patient care standards and practices.