Clinical Research Quality Control (QC) Associate

CenExel is a nationwide clinical research site and patient network serving the life sciences industry. The Clinical Research Quality Control (QC) Associate ensures the accuracy, consistency, and integrity of clinical trial documentation and processes by reviewing trial documents and clinical data for compliance with GCP, ICH guidelines, regulatory requirements, and company SOPs.

Responsibilities

• Performs quality control reviews of clinical trial documents (e.g., informed consent forms, case report forms, regulatory binders, monitoring visit reports) to ensure accuracy, completeness, and consistency
• Identifies discrepancies, deviations, or data entry errors and follow up with appropriate teams for resolution
• Supports the preparation and QC of Trial Master File (TMF) documents (paper and/or electronic)
• Assists in internal audits and inspection readiness activities
• Collaborates with cross-functional teams (clinical operations, data management, regulatory affairs) to maintain high standards in documentation practices
• Maintains and tracks QC metrics and contribute to quality improvement initiatives
• Ensures that all clinical documentation complies with GCP, ICH, FDA, EMA, and company SOPs
• Assists with SOP development and updates related to quality control activities
• Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive

Preferred

• Bachelor's degree in life sciences, healthcare, or a related field (preferred)
• Experience with electronic systems such as eTMF, EDC, and CTMS preferred
• Certification in clinical research (e.g., ACRP, SOCRA) is a plus
• Life Sciences Degree
• Healthcare Degree
• eTMF
• EDC
• CTMS
• Clinical Research Certification
• ACRP Certification
• SOCRA Certification

Benefits

• Health Insurance for full-time employees after 30 days of employment
• Dental Insurance for full-time employees after 30 days of employment
• Vision Insurance for full-time employees after 30 days of employment
• Long-term disability (LTD) insurance for full-time employees after 30 days of employment
• Short-term disability (STD) insurance for full-time employees after 30 days of employment
• Life insurance for full-time employees after 30 days of employment
• 401k for full-time employees after 30 days of employment
• Remote work arrangement

Company

• Clinical research site network for complex pharmaceutical trials
• Salt Lake City, Utah, USA
• http://www.cenexelresearch.com/
• Founded in 2018
• 1001-5000 employees

Qualifications

• Must be able to effectively communicate verbally and in writing
• 1–3 years of experience in clinical research, with at least 1 year in a QC, QA, or documentation review role
• Familiarity with clinical trial processes and regulatory requirements (GCP, ICH, FDA, EMA)
• Strong attention to detail and organizational skills
• Excellent written and verbal communication
• Ability to work independently and in a team-oriented environment
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)
• Experience in Phase I–IV trials or in a CRO environment
• Bachelor's degree in life sciences, healthcare, or a related field (preferred)
• Experience with electronic systems such as eTMF, EDC, and CTMS preferred
• Certification in clinical research (e.g., ACRP, SOCRA) is a plus

Required skills

• Clinical Research, Quality Control and Quality Assurance, Clinical Documentation Review, Clinical Practice (GCP), ICH Guidelines, FDA Regulations, EMA Regulations, eTMF, EDC, CTMS, Microsoft Office Word, Microsoft Office Excel, Microsoft Office Outlook, Microsoft Office PowerPoint, ACRP or SOCRA Certification, Phase I–IV Clinical Trials

Experience

• 1-3 years