We've got a great role in Central London to help our client's team grow their clinical quality team. Ideally, we are looking for a Senior Clinical Quality Specialist. We can consider a more junior candidate or a CRA or Clinical Project Manager looking to move into QA. 

Our client is a leading provider of oncology research and healthcare. The role of the QA is to Support process improvement, and internal/external audits within the Investigative Site serving as the internal quality contact and resource for the department to support quality initiatives and projects.

There are interesting projects such as growing the team and implementing a new QMS Quality Management System. Ideally, you will be used to working with US and global companies to help them apply FDA regulations to MHRA and EMA regulations. 

Duties and Responsibilities:

- Develop and maintains effective relationships with the investigative site and other departments and colleagues

- Mentors and works closely with the other Clinical Quality Specialists to ensure consistent support and effective outcomes for the investigative sites

- Prepares for and hosts external sponsor / IRB audits

- Investigates and responds to Corrective and Preventive Action (CAPA) requests in collaboration with Clinical Operations and CQA.

- Works with Clinical Operations to obtain evidence of deliverables and facilitates effectiveness checks as needed to ensure CAPA closure.

- Reviews monitor letters for issue escalation and quality performance issues

- Develops a calendar for monitoring quality indicators/quality check (QC) and provides routine reporting of variances to the appropriate Clinical Quality Assurance (CQA) staff and operational leadership

- Identifies areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate CQA staff.

- Coordinates and facilitates quality review meetings with appropriate CQA staff and operational leadership

- Communicates with monitors and auditors as needed

- Monitors, coordinates, and assists with procedure modification for quality management as required.

- Assists in development and modification of departmental work instructions and collaborates with appropriate CQA staff to ensure alignment with SOPs

- Educates research staff in quality improvement methods

- Assists research staff in maintaining FDA compliance

- Performs related work as required

- All other duties as assigned

- Travel as required to meet the needs of the investigative site

Mandatory:

- Practices and adheres to the "Code of Conduct" philosophy and "Mission and Value Statement"

- During your employment with the client you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.

Competencies

Knowledge: A body of information needed to perform tasks; May be obtained through education, training or experience

- Medical and clinical research terminology

- FDA Regulations MHRA EMA and GCP Guidelines

Skills: The proficiency to perform a certain task

- Interpersonal, communication, and organizational skills

- Problem solving skills

- MS Office

Abilities: An underlying, enduring trait useful for performing duties

- Ability to work within deadlines

- Customer-focused

- Relationship building

- Analytical

- Organized, ability to prioritize

- Detail-oriented and meticulous

Minimum Qualifications

Bachelor's Degree or Master's Degree

Seven + years experience in Healthcare research or other science-related field

Quality Assurance consulting and auditing experience in a GxP environment

#GCP #QualityAssurance #Oncology