FLSA STATUSExemptQUALIFICATIONSEDUCATIONBachelor's degree in life sciences or related field from an accredited college or universityEXPERIENCEThree years Clinical Trial Coordinator or equivalent experienceQuality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics or pharmaceuticals desirableRegulatory audit exposure with US-FDA preferredLICENSES AND CERTIFICATIONSRequired : Must have one of the following certifications: CCRP, CCRA, CCRC, ACRP-CP within 1 yearPreferred : Certification in Quality Auditing or Quality AssuranceKNOWLEDGE AND ABILITIESDemonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluationsSufficient 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 securityAbility 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 principlesExcellent working knowledge of FDA regulations and GCP guidelinesExcellent written and oral communication skillsExcellent working knowledge of the clinical trial operationsAbility to develop Quality Assurance strategy and implementationAbility to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic, flexible, and constructive mannerAbility to work in a team environment with effective leadership skillsESSENTIAL FUNCTIONSPEOPLE ESSENTIAL FUNCTIONSAssists institutional investigators and other members of the research team, by providing education and training regarding processes and procedures governing clinical research activities which can be ad-hoc, remote/teleconferences, or face-to-face sessions with the entire research team.Partners with specific research teams to identify potential changes and opportunities for improvement, within department and/or study-specific SOPs, policies, training materials, and other documents, as needed.Promotes a positive work environment and contributes to a dynamic, team-focused work unit that actively helps one another to achieve optimal department results. Encourages interdepartmental, as well as institution-wide communication, as it relates to clinical research studies.Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.SERVICE ESSENTIAL FUNCTIONSEducates and mentors research team with interpretation of regulatory requirements, e.g., GCPs, SOP requirements, and other guidance documents, as applicable.Assists other Research Protections staff, as needed, including IRB, IBC, RSC, and HSC. Provides timely feedback to stakeholders to facilitate swift and efficient process improvement.Evaluates site readiness based on HMRI standards prior to start date of a new clinical trial.QUALITY/SAFETY ESSENTIAL FUNCTIONSConducts feasibility assessments, ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness. Develops site-specific education and processes within specified research teams.Coordinates monthly Clinical Research Education Series, the Clinical Research Orientation Program (CROP), and the annual Clinical Research Conference.Meets regularly with the clinical trial manager(s) and Principal Investigators (PIs) to discuss quality/compliance trends.Monitors and evaluates ongoing quality and compliance standards, along with regulatory and clinical trial trends/actions, with regular reports to QA management. Assists with preparation and/or assists during regulatory inspections.FINANCE ESSENTIAL FUNCTIONSIdentifies cost saving initiatives within the department and communicates recommendations to Sr Quality Assurance Analyst and/or management.Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed.GROWTH/INNOVATION ESSENTIAL FUNCTIONSAnalyzes responses to monitoring and audit reports; collaborates with the research team to follow-up with respondents, management, or others, if needed, to ensure resolution.Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.SUPPLEMENTAL REQUIREMENTSWORK ATTIREUniform: NoScrubs: NoBusiness professional: YesOther (department approved): YesON-CALL**Note that employees may be required to be on-call during emergencies (e.g., Disaster, Severe Weather Events, etc) regardless of selection below.On Call* NoTRAVEL****Travel specifications may vary by department**May require travel within the Houston Metropolitan area YesMay require travel outside Houston Metropolitan area No#J-18808-Ljbffr