Accomplished and energetic clinical regulatory specialist with a solid history of achievement in managing multiple studies in a organized, comprehensive manner. Managed over 40 studies at two sites over a six year period with no assistance. Accepts responsibility and takes ownership of duties assigned to me. Works well with others, respecting and welcoming diverse ideas and innovative ways to best accomplish a common goal. Strong desire to work in a cohesive, collaborative environment.
Over 30 years of experience in medical environments Able to work independently, self directed, strong work ethic
Over ten consecutive years of research experience Currently managing regulatory oversight for over 45 projects, including cardiovascular, bariatric, trauma, and emergency medicine studies
Strong belief in teamwork, values, positive relationships and respect in the workplace
Prepare all new study start up documents for sponsor and IRB submission.
Prepare and submit documents to the IRB for review and approval of amendments, continuing review, administrative letters, advertisements, patient materials, etc.
Maintain regulatory binders for completeness through life span of study. Insure that binders are in organized, comprehensive order for monitoring visits and/or audits
Assist research staff in development of regulatory documents, including informed consents
Develop and maintain tracking tools to manage deadlines and timelines in the submission of time sensitive documents
Assist study team with training in Good Clinical Practices, Protection of Human Subjects and other compliance requirements.
Prepared and submitted documents to sponsors and a large number of IRBs.
Managed all written documents pertaining to study trials
Responsible for organization and maintenance of study binders
Tracked sponsor payments and patient stipends
Managed physicians schedule for meetings, speaking engagements and travel
Handled accounts payable and bookkeeping duties for surgery center
Managed payroll for three sites
Managed accounts receivable staff of six people for three sites
Worked closely with accountant and outside vendors
Cuyahoga Heights ,Ohio
About this resume
This is a resume for a Regulatory Specialist in Mesa, Arizona with experience working for such companies as HonorHealth and Scottsdale Cardiovascular Research Institute. The grade for this resume is 0 and is one of hundreds of Regulatory Specialist resumes available on our site for free. Use these resumes as templates to get help creating the best Regulatory Specialist resume.