[Hiring] Clinical Research Quality Control Associate @CenExel

Role Description

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.

• 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 follows 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 contributes 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 strict 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.

Qualifications

• 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.

Requirements

• 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).

Benefits

• Highly competitive compensation.
• Generous benefits package to full-time employees after 30 days of employment including:
• Health Insurance
• Dental
• Vision
• LTD
• STD
• Life Insurance
• 401k