Clinical Research Quality Control (QC) Associate
CenExel
Summary
The Clinical Research Quality Control (QC) Associate is responsible for ensuring the accuracy, consistency, and integrity of clinical trial documentation and processes. Working closely with clinical operations, data management, and regulatory teams, the QC Associate reviews essential trial documents and clinical data to verify compliance with GCP (Good Clinical Practice), ICH guidelines, regulatory requirements, and internal SOPs.
Job description
Essential Responsibilities and Duties
- 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.
Education/Experience/Skills
- Must be able to effectively communicate verbally and in writing.
- Bachelor’s degree in life sciences, healthcare, or a related field (preferred)
- 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).
- Experience with electronic systems such as eTMF, EDC, and CTMS preferred.
- 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).
- Certification in clinical research (e.g., ACRP, SOCRA) is a plus.
- Experience in Phase I–IV trials or in a CRO environment.
Working Conditions
- Indoor, Office environment.
- Indoor, Clinic environment.
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position, occasional lifting of up to 20 pounds.
- Reporting to work, as scheduled, is essential.
- Remote work arrangement.
- Occasional travel may be required (e.g., for audits or training).
Requirements
- Must be able to effectively communicate verbally and in writing.
- Bachelor’s degree in life sciences, healthcare, or a related field (preferred)
- 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).
- Experience with electronic systems such as eTMF, EDC, and CTMS preferred.
- 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).
- 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 Insurance
- 401k
Company overview
CenExel is a leading integrated clinical research site network operating across major metropolitan areas throughout the United States. Founded in 2018 and headquartered in Salt Lake City, Utah, the company operates 18 Centers of Excellence that collectively represent over 40 years of clinical research experience. CenExel specializes in providing comprehensive clinical trial services to pharmaceutical companies, biotechnology firms, and clinical research organizations, with particular expertise in central nervous system (CNS) disorders and early-phase clinical research. The company's nationwide network delivers deep scientific expertise, premium data quality, operational efficiencies, and exceptional patient engagement to drive successful clinical trial outcomes. With more than 1,200 employees across its network, CenExel focuses on accelerating the development of life-changing therapies through its patient-centered approach and commitment to research excellence. The company serves as a strategic partner for sponsors seeking to optimize clinical trial performance, from site selection through study close-out, while maintaining rigorous standards for patient care and scientific integrity.