CovarsaDx is seeking a dedicated and detail-oriented Quality/TMF Administration Assistant to play a pivotal role in managing Trial Master Files (TMF) and supporting our quality management team. This full-time, on-site position offers the opportunity to contribute to clinical research excellence and ensure compliance with regulatory requirements in a dynamic and innovative environment. Explore how you can make an impact with us!
About Us
CovarsaDx is a clinical research organization (CRO) that is dedicated to clinical studies for IVD (in vitro diagnostic) and medical device trials. Our clients experience personalized study strategies, expert consultation, and agile adaptation to changing trial design requirements. We prioritize our clients’ regulatory success and clinical research experience, supported by trusted clinical research specialists and resources.
Position Description
As a Quality/TMF Administration Assistant, you will be responsible for the management and maintenance of trial master files for clinical trials conducted by our organization and provide administrative support to our quality management team. You will assist in maintaining quality management systems, tracking key performance indicators, and ensuring compliance with regulatory requirements. This is a full-time on-site role located in Downey, CA.
Key Responsibilities:
- Documentation Management:
- Review and organize documents for completeness, accuracy, and compliance with regulatory requirements. Maintain and update quality management documentation, including policies, procedures, and quality records. Manage the version control and distribution of essential documents. Ensure that all essential documentation for the Quality System and Trial Masters Files are collected, filed and are accurate, up-to-date, and easily accessible.
- Compliance Monitoring:
- Ensure that trial master files are maintained in compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs.
- Support quality audits and investigations as needed.
- Quality Improvement Support:
- Assist in coordinating quality improvement initiatives and projects. Track progress and outcomes of quality improvement activities.
- Training and Education:
- Assist in the development and implementation of training programs related to quality management and compliance. Ensure all training and employee records are filed.
- Quality Control and Assurance:
- Perform regular quality checks to ensure the integrity and completeness of trial master files.
- Identify and address any discrepancies or deficiencies in documentation.
- All other related duties as requested and assigned.
Qualifications:
Bachelor’s degree in a scientific or healthcare-related field.
Minimum of 2 years of experience in clinical research, with specific experience in quality and/or trial master file management preferred.
Strong knowledge of regulatory requirements and GCP guidelines.
Excellent organizational skills and attention to detail.
Proficiency in document management systems and Microsoft Office Suite.
Ability to work independently and collaboratively as part of a team.
Strong communication and interpersonal skills.
Benefits:
Competitive salary with quarterly bonus
Health, dental, and vision insurance
Retirement savings plan
Paid time off and holidays
Opportunities for professional development and advancement
How to Apply:
Please submit your resume and cover letter to hr@covarsadx.com. In your cover letter, please include a brief summary of why you are interested in this position and how your skills and experience make you a strong candidate.