CenExel · 15 hours ago
Quality Control Associate
Decatur, GA
Full-time
Hybrid
Entry Level
1+ years expCenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. The Clinical Research Quality Control (QC) Associate is responsible for ensuring the accuracy, consistency, and integrity of clinical trial documentation and processes by reviewing essential trial documents and clinical data for compliance with regulations and internal standards.
Clinical TrialsHealth CarePharmaceutical
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
Qualification
Required
Bachelor's degree in life sciences, healthcare, or a related field required
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)
Must be able to effectively communicate verbally and in writing
Preferred
Advanced degree preferred
Experience with electronic systems such as eTMF, EDC, and CTMS preferred
Certification in clinical research (e.g., ACRP, SOCRA) is a plus
Experience in Phase I–IV trials or in a CRO environment
Benefits
Health Insurance
Dental
Vision
LTD
STD
Life Ins
401k
Company
CenExel
CenExel is a clinical research site network supporting phase I-IV clinical trials. It is a sub-organization of Webster Equity Partners.
1001-5000 employees
H1B Sponsorship
CenExel has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2025-04-12Acquired
2023-04-01Private Equity
Leadership Team
Patrick McLaughlin
Chief Operating Officer
Recent News
Venture Capital Firms
2025-10-16
Company data provided by crunchbase