p>QUALIFICATIONSEDUCATION Bachelor's degree in life sciences or related field from an accredited college or university EXPERIENCE Three years Clinical Trial Coordinator or equivalent experience Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics or pharmaceuticals desirable Regulatory audit exposure with US-FDA preferred LICENSES AND CERTIFICATIONSRequired Must have one of the following certifications: CCRP, CCRA, CCRC, ACRP-CP within 1 year Preferred Certification in Quality Auditing or Quality Assurance KNOWLEDGE AND ABILITIESDemonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles Excellent working knowledge of FDA regulations and GCP guidelines Excellent written and oral communication skills Excellent working knowledge of the clinical trial operations Ability to develop Quality Assurance strategy and implementation Ability to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic, flexible, and constructive manner Ability to work in a team environment with effective leadership skills. On Call No. TRAVEL**Travel specifications may vary by departmentMay require travel within the Houston Metropolitan area Yes May require travel outside Houston Metropolitan area No.
QUALIFICATIONSEDUCATION Bachelor's degree in life sciences or related field from an accredited college or university EXPERIENCE Three years Clinical Trial Coordinator or equivalent experience Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics or pharmaceuticals desirable Regulatory audit exposure with US-FDA preferred LICENSES AND CERTIFICATIONSRequired Must have one of the following certifications: CCRP, CCRA, CCRC, ACRP-CP within 1 year Preferred Certification in Quality Auditing or Quality Assurance.