Clinical Research, Internal Quality Assurance Associate

Castle Biosciences•Phoenix, AZ

5d•Onsite

About The Position

The Internal Quality Assurance Associate supports the daily operations of the Clinical Research Department's quality assurance activities, including SOP development, audit preparation, and staff training. The role contributes to the ongoing enhancement of the department's Quality Management System and helps promote a strong quality‑focused culture. Collaboration with Clinical Research, Quality, and Training teams is essential to identify quality issues, assess regulatory and compliance risks, and assist in implementing corrective and preventive actions. The position also plays a key role in internal and external audits by preparing documentation, organizing metrics, and supporting responses to findings. Responsibilities include assisting in the development, implementation, and maintenance of quality assurance plans, protocols, SOPs, and other controlled documents. This position manages document control and learning management systems to ensure accurate version control, record retention, training documentation, and regulatory compliance. Additional duties include supporting the organization and accessibility of training materials, conducting periodic system audits, and providing technical assistance to document control and LMS users. All activities are carried out in alignment with Castle policies, good clinical practice, and applicable regulatory requirements while upholding professionalism and human subject protection standards.

Requirements

Associate degree in related field.
Minimum of 2 years of proven experience in clinical quality assurance, compliance, regulatory, or a related role.
A minimum of 2 years in clinical research.
Actively displays behaviors that support the mission, vision, and values of Castle Biosciences.

Nice To Haves

Bachelor's degree in related field or demonstrated experience as evidence of competency.
Previous experience with complex, global trials.
Current knowledge of U.S., European and/or global regulations and standards covering clinical research.
Basic understanding of ISO 14155 and ISO 13485.

Responsibilities

Supports the daily operations of the Clinical Research Department's quality assurance activities, including SOP development, audit preparation, and staff training.
Contributes to the ongoing enhancement of the department's Quality Management System and helps promote a strong quality‑focused culture.
Collaborates with Clinical Research, Quality, and Training teams to identify quality issues, assess regulatory and compliance risks, and assist in implementing corrective and preventive actions.
Plays a key role in internal and external audits by preparing documentation, organizing metrics, and supporting responses to findings.
Assists in the development, implementation, and maintenance of quality assurance plans, protocols, SOPs, and other controlled documents.
Manages document control and learning management systems to ensure accurate version control, record retention, training documentation, and regulatory compliance.
Supports the organization and accessibility of training materials.
Conducts periodic system audits.
Provides technical assistance to document control and LMS users.
Carries out all activities in alignment with Castle policies, good clinical practice, and applicable regulatory requirements while upholding professionalism and human subject protection standards.