Clinical Quality Assurance Specialist

POSITION SUMMARY: 

The Clinical Quality Assurance Specialist is responsible for quality oversight and support of Be The Match’s clinical research program. This role will support clinical quality management via development, implementation and management of quality assurance procedures.

ACCOUNTABILITIES: 

• Oversees clinical SOPs and process documents to ensure alignment with applicable regulations.
• Monitors industry trends and engages with operational teams to proactively implement best practices.
• Proactively engages with study teams to ensure inspection readiness.
• Clinical quality point of contact for internal and investigator audits and serve as an auditor on both internal audit and supplier audit teams.
• Develops training materials for research teams and collaborates to execute training.
• Provides day-to-day guidance in interpreting regulations and operationalizing.
• Reviews data to identify trends and implements appropriate process improvement strategies.
• Collaborates with study team to develop Corrective and Preventative Action Plans (CAPAs) as necessary.
• Liaisons with Be The Match Quality Assurance to align with broad company quality goals and initiatives.
• Models teamwork and maintains a positive working environment.
• Fosters a collaborative working relationship with other functional areas.
• Supports operational metrics reporting.
• Maintains a professional demeanor during all external interactions with physicians and study sponsor representatives.
• Other duties as assigned.