Position Summary The Clinical Research QA Specialist is responsible for monitoring and developing processes to assure the Research Department Clinical Teams meet and/or exceed research standards of accurate and quality work. Actively engages in the prevention, detection, and resolution of instances of conduct that do not conform to protocol requirements, SRHS policies and procedures, FDA regulations, Good Clinical Practices, and IRB policies.
Collaborates closely with Clinical Research Team, which may include Clinical Research Nurses/ Coordinators, the Principal Investigator (PI), Managers, the Research Pharmacist(s), Sub-Investigators and Regulatory staff to ensure that key federal/state/local regulatory objectives are met; and that ethical obligations are kept. Educates staff and affiliate sites in conjunction with Regulatory Team on current and changing FDA regulations, ICH guidelines, and SOPs. Reports status of overall quality on a regular basis, including summary information across all therapeutic areas, industry studies, NCI studies, and affiliate research sites. # # # Minimum Requirements # Education
(BA, BS, BSN) Experience
2 to 5 years of progressive QA experience 1+ year#s oncology experience # License/Registration/Certifications
Current South Carolina RN license (for nurse applicants) # Other Knowledge, Skills, Abilities###
Electronic Medical Record (EMR) MS Office proficiency:# Word, Excel, PowerPoint, Outlook Knowledge of HIPAA privacy information standards # Preferred Requirements # Preferred Education
(NCI) and Industry Sponsored Trials # Preferred License/Registration/Certifications
(ACRP, SoCRA) # Core Job Responsibilities Experience with interpreting complex protocols, subject records, and federal, state, and local regulations preferred. Routinely audits patient charts and associated case report forms to assure compliance and quality control.
Responsible for preparation, scheduling, facilitation, and management of all external audits. Responsible for creating and managing corrective and preventative action plans in response to internal and external audits. Demonstrated knowledge of medical terminology and regulatory compliance.
May attend relevant symposia, conferences and scientific meetings as necessary. Acute awareness of confidentiality of information. This individual must be able to work as a member of a team, manage conflicts and resolve problems effectively.
Performs other duties as requested. # # # # Physical Requirements Must be meticulous with detail. Must be able to read, write, and speak English fluently. Must have good communication skills.
Must be able to respond calmly and efficiently in high stress situations. Must be able to sit for long periods of time, filling out paperwork. Must have own transportation to other hospitals and doctors# offices.
Must be flexible in responsibilities and work schedule. Must be self-directed and able to work without supervisor. #
Spartanburg Regional Medical Center