Quality Assurance Specialist
2 weeks ago
Provides clinical trials auditing andmonitoring and follows established processes to support compliance according toKCI Data and Safety Monitoring Plan (DSMP) and all applicable regulations.Provides support for all facets of clinical trials auditing and monitoring withspecial emphasis on institutional (investigator-initiated) and CooperativeGroup sponsored trials. This position is integral to the overall compliance ofclinical trial research and the protection of the rights and well-being of studyparticipants. Facilitates excellentcustomer service and guidance in the clinical trial compliance arena. Abilityto manage independent assignments.
Responsibilities:
Conducts a variety of compliance activitiesintended to facilitate and assure that clinical trials comply with therequirements of the protocol, the approving Institutional Review Board, Code ofFederal Regulations, Good Clinical Practice, Food and Drug Administration(FDA), and KCI's NCI approved Data and Safety Monitoring Plan. Conducts auditing and monitoring activities inaccordance with established CTO policies and procedures. Activities may include: pre-study feasibilityevaluations, ongoing monitoring of studies and study close-out, drug, deviceand correlative specimen compliance review. Reviews the accuracy, completeness andtimeliness of study related records, and case report forms with original sourcedocuments. Reviews that study related processes relativeto departmental guidelines and SOPs are in compliance. Bachelor's degree and four plus years' experience coordinating clinical trials: or equivalent combination of education/experience that includes at least five years in the clinical trials arena. Medical and/or science experience/education strongly preferred. Clinical research certification required for a minimum of one year. Clinical trial auditing and monitoring experience preferred. Proficient with the Microsoft suite including Excel and Power point. Exceptional interpersonal skills required and excellent verbal and written communication skills necessary to effectively deal with individuals both inside and outside the organization from diversified backgrounds. Skilled in communicating sensitive/difficult information and maintaining highly confidential information and situations. Demonstrated high level of interpersonal skills and analytical ability. Excellent writing and organizational skills. Demonstrated leadership abilities required. Demonstrated initiative and attention to detail.Equal Opportunity Employer of Minorities/Females/Disabled/Veterans
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