Clinical Operations Clinical QC Consultant-REMOTE New York, New York
Orbis Clinical is seeking a remote-based Clinical QC Consultant for 6 months.
Title: Clinical QC Consultant
Location: US-Remote (east coast preferred)
Initial Contract: 6-months with potential for extension and/or full-time conversion depending on multiple factors such as performance
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
- Prior experience in a biotech or pharmaceutical company Required
- 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 focus areas: GI and inflammation)
- Familiarity with electronic systems such as Veeva Vault, Medidata, or similar
Key Skills
- Quality control and audit readiness
- Documentation review and compliance
- Communication and collaboration
- Problem-solving and critical thinking
Work Environment
- Contract/consultant role
- Remote
- Will require collaboration across global teams
Compensation Details:
- Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $90.00 – $104.50 hour, can vary depending on employment status.
- Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.
EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
