Specialist- Clinical Research QA

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 Coordinators, Principal Investigator (PI), Managers, Research Pharmacist(s), Sub-Investigators and Regulatory staff, to ensure that key federal/state/local regulatory objectives are met; and 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         

• Bachelor’s in health related field (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 standard

Preferred Requirements

Preferred Education     

• Master’s in science or health related field

Preferred Experience    

• Clinical Trial Monitoring Experience
• National Cancer Institute (NCI) and Industry Sponsored Trials

Preferred License/Registration/Certifications    

• Clinical Research Professional (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.

• 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.