Clinical QC Consultant – Job Description Position Overview The Clinical QC Consultant is responsible for ensuring the quality, accuracy, and compliance of clinical trial documentation and data. This role supports clinical operations by performing quality control reviews and ensuring adherence to regulatory requirements and internal standards.
Key Responsibilities
Perform QC review of clinical documents, including:
Clinical study reports (CSRs)
Protocols and protocol amendments
Informed consent forms (ICFs)
Monitoring visit reports
Trial master file (TMF) documents
Ensure compliance with:
Food and Drug Administration (FDA) regulations
International Council for Harmonisation (ICH) guidelines
Good Clinical Practice (GCP) standards
Verify data accuracy and consistency across clinical systems (e.g., EDC, CTMS, TMF)
Identify discrepancies, errors, or missing information and communicate findings to clinical teams
Ensure proper documentation, version control, and audit readiness
Support inspection readiness activities and participate in internal audits
Collaborate with cross-functional teams including Clinical Operations, Data Management, and Regulatory Affairs
Assist in the preparation of protocols (including the writing of administrative letters for protocols and summary of changes for protocol amendments) and CSRs.
Assist in the preparation of study-level documentation required for clinical trials (e.g., CSR appendices, shell drafts)
Edit CSR statistical analysis plans and table/figure/listing specifications for grammar, format, and consistency.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field
5+ years of experience in clinical research, QA/QC, or clinical operations
Strong knowledge of FDA regulations, ICH guidelines, and GCP
Experience reviewing clinical trial documentation and TMF management
High attention to detail and strong analytical skills
Preferred Qualifications
Experience in hepatology or rare disease clinical trials (relevant to Intercept's focus areas)
Prior experience in a biotech or pharmaceutical company
Familiarity with electronic systems such as Veeva Vault, Medidata, or similar