Medical University of South Carolina
UNIV - Quality Assurance Auditor and Education Specialist - Hollings Cancer Cent
Medical University of South Carolina, Charleston, South Carolina, United States, 29401
Quality Assurance Auditor and Education Specialist - Hollings Cancer Center
Charleston, South Carolina The Internal Quality Assurance Auditor and Education Specialist is an integral part of the Clinical Trials Office (CTO). This role focuses on implementing research quality assurance measures and overseeing the education, orientation, and continuous professional development of staff. Responsibilities include conducting various human subject clinical trial audits within the CTO to ensure protocol compliance, collaborating with the QAE Program Manager to onboard and train CTO staff on Standard Operating Procedures (SOPs), MUSC IRB policies, Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and ICH Guidelines. Additionally, the role involves tracking audits and high-risk monitoring activities in the OnCore clinical trial management system (CTMS) and supporting the QAE team leadership in executing special projects and duties to enhance new initiatives or process improvement pilots. Qualifications for this position include in-depth knowledge of federal, state, institutional, IRB, and CTO regulations and policies, strong understanding of FDA, GCP, and ICH regulations, and proven ability to train and educate staff on complex research, regulatory, and procedural topics. Minimum Requirements: A bachelor's degree and three years of relevant program experience. Physical Requirements include the ability to perform job functions in an upright position, seated position, and while walking/mobile, work indoors, and possess good finger dexterity, among other physical capabilities. The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.
Charleston, South Carolina The Internal Quality Assurance Auditor and Education Specialist is an integral part of the Clinical Trials Office (CTO). This role focuses on implementing research quality assurance measures and overseeing the education, orientation, and continuous professional development of staff. Responsibilities include conducting various human subject clinical trial audits within the CTO to ensure protocol compliance, collaborating with the QAE Program Manager to onboard and train CTO staff on Standard Operating Procedures (SOPs), MUSC IRB policies, Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and ICH Guidelines. Additionally, the role involves tracking audits and high-risk monitoring activities in the OnCore clinical trial management system (CTMS) and supporting the QAE team leadership in executing special projects and duties to enhance new initiatives or process improvement pilots. Qualifications for this position include in-depth knowledge of federal, state, institutional, IRB, and CTO regulations and policies, strong understanding of FDA, GCP, and ICH regulations, and proven ability to train and educate staff on complex research, regulatory, and procedural topics. Minimum Requirements: A bachelor's degree and three years of relevant program experience. Physical Requirements include the ability to perform job functions in an upright position, seated position, and while walking/mobile, work indoors, and possess good finger dexterity, among other physical capabilities. The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.