Quality Assurance Specialist
University Code 34114 University Title Senior Clinical Research Coordinator 1 University Job Family Research - Support ORP Eligible No For more information on ORP, visit: Retirement Plans
Recruitment Pool All Applicants Recruitment Type Single Title Scope of Search Local Working Title Quality Assurance Specialist Position Number 592740 Is this employee on a H1B Visa? Position Type Staff Job Status Full-Time FLSA Indicator Exempt Employee Group University Employee Department Neurology Organizational Overview
At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.
Position Primary Purpose and General Responsibilities
This position would perform quality assurance activities within the Muscular Dystrophy Translational Research Program. The Muscular Dystrophy Translational Research Program provides central coordination support for two multinational networks in the muscular dystrophies. These studies include natural history studies as well as therapeutic trials. There is a need to support study monitoring activities. In this role the individual would conduct quality assurance reviews of studies, internally and within networks, to determine compliance with study protocols, Good Clinical Practices, and policies and procedures. He or she would provide support to prepare for external ( FDA, sponsor, etc.) audits. He or she would coordinate with training functions within the program to identify training opportunities to improve study management compliance. He or she would perform clinicaltrials.gov activities. He or she would coordinate audit response and corrective and preventative action submission.
Minimum Hiring Standards
Bachelors Degree or equivalent related 5+ years experience: Clinical Research Coordinator certification required ( CCRC, CCRP, CCRA . Prior experience monitoring studies. Must be able to complete mandatory competencies and certifications required by VCU, individual clinical trials, and the NIH Human Subject Protection training required by federal regulations for research. Communication skills, written and spoken are essential. Ability to work in a diverse environment is required.
Preferred Hiring Standards
Masters Degree preferred. Experience in human subjects research with participants with neurological disorders. Familiarity with REDCap Cloud database and Veeva Sitevault. Prior study management and/or neurological patient care experience preferred.
Required Licenses/ Certifications Anticipated Hiring Range $75,000 - $85,000 Application Process/Additional Information Campus MCV Campus Hours/Week 40 Normal Work Days/Hours M-F Job Open Date 05/27/2021 Posting will close on or before Open Until Filled Yes Job Category Research Is this a restricted position? Yes Is this position eligible to participate in alternative work arrangements? No Sensitive Position Yes- A pre-employment fingerprint background check will be required. Resource Critical No Quick Link https://www.vcujobs.com/postings/106421 Posting Specific Questions
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Optional & Required Documents
- Cover Letter/Letter of Application