Alaka`ina Foundation Family of Companies is looking for a Quality Assurance Officer to support our government customer on site in Silver Spring, Maryland.
Responsible for all onsite Clinical Trial activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Facilitate quality assurance monitoring by study sponsors. Relies on experience and judgment to plan and accomplish goals and tasks. Performs a variety of tasks. May lead and direct the work of others.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

• Must have an Associate’s degree and four plus (4+) years of experience.
• Bachelor’s degree is preferred.
• Minimum of five (5) years of experience in quality assurance for clinical trials, with expertise in ICH/GCP compliance.
• Certification in quality management (e.g., ASQ or equivalent) is preferred.

• Responsible for Quality Assurance/Regulatory Compliance of all onsite Clinical Trial activities
• Conducts audits and reviews/analyzes data and documentation. This includes internal audits such as the laboratory.
• Develops, maintains, and ensures compliance with Standard Operating Procedures (SOPs), be knowledgeable and compliant with all Human Subjects’ Protection, FDA, and current Good Clinical Practice (GCPs) regulations as well as ensuring all contractor study personnel remain trained and up to date in their respective fields.
• Facilitates quality assurance monitoring by study sponsors.
• Relying on experience and judgment to plan and accomplish goals and tasks.
• Prepares and maintains instructions and pre-established guidelines to perform the functions of the job.
• Coordinates with entire Clinical Trials Center (CTC) team to ensure compliance for all studies regardless of study phase.
• Ensures successful completion of all internal and external audits, assists Clinical Research Coordinator (CRC) with regulatory compliance, maintains staff credentials, provides Quality Control of all source documents, conducts chart review, and updates SOPs as necessary.
• Prepares monthly status report and performs a variety of tasks. May lead/direct the work of others.
• Other duties as assigned by Supervisor.