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Michele O.

Michele O.

Clinical Research and Quality Assurance Professional

Management of multiple world-wide clinical trials in the therapeutic areas of cardiology, pulmonary, neurology, aesthetics, women’s healthcare, and peripheral vascular applications. Development and management of Quality Assurance System (SOPs, controlled forms, work instructions, study plans, and other study related procedures and systems.) Conducted sponsor audits for compliance with applicable regulations and standards, such as Good Clinical Practice (GCP) guidelines, FDA regulations, ISO 14155, Declaration of Helsinki, internal company SOPs and other internal company procedures. Development of Clinical Investigational Plans and Study Support Documents. Management and coordination of clinical trial Core laboratories, Clinical Events Committees (CEC) and Data Safety Monitoring Boards (DSMB). Development and management of company Quality Management Systems (QMS). Management of Clinical Trial site start-up, management, monitoring and close-out of multiple clinical sites. Managed data management / data handling for various study sponsors. Participated in FDA inspection.

🇺🇸Carmel Valley, United States$80/hr80% JSS5.00 (1)Since Aug 2017

Earnings and projects

MRR (estimate)
≈$0

An estimate from an earlier read

World#387,261 / 412k
🇺🇸Country#59,127 / 62.1k
Revenue, last 30 days
$0
Total earnings
$1.1k
World#387,261 / 412k
🇺🇸Country#59,127 / 62.1k
Per project
$544
Projects, last 6 months
0
World#209,850 / 412k
🇺🇸Country#27,405 / 62.1k
Projects in all
2
0% fixed100% hourly
World#328,886 / 412k
🇺🇸Country#47,959 / 62.1k

Earnings, last 30 days

$1.1kNothing earned in the last 30 daysBilled in all, before Upwork's fee · drag across the chart to see what was earned in any stretch
$1,060$1,080$1,100$1,120Oct 9Oct 24Nov 8

Dotted: longer than usual between two readings.

Skills