Position Summary
Monroe Biomedical Research is seeking an experienced Quality Control (QC) Specialist to support the quality and compliance of clinical research activities across our clinical research sites.
The QC Specialist is responsible for conducting timely and thorough quality control reviews of clinical research participant visit documentation within CRIO. This position reviews source documentation against study protocols, CRF Completion Guidelines, laboratory manuals, pharmacy manuals, imaging manuals, sponsor guidance, and other study-specific documentation to ensure accuracy, completeness, consistency, and protocol compliance.
The ideal candidate has strong clinical research experience, exceptional attention to detail, and the ability to independently interpret complex clinical trial protocols and identify documentation deficiencies, potential protocol deviations, safety reporting concerns, and endpoint-related issues.
The QC Specialist will communicate findings clearly to Clinical Research Coordinators and other designated research staff and track identified findings through resolution.
Note: We will only consider candidates with experience with site-level clinical research experience. NO Pharmaceutical Manufacturing QC.
Key Responsibilities
Quality Control Review
- Perform daily quality control reviews of completed clinical research participant visits within CRIO.
- Review source documentation for accuracy, completeness, consistency, and compliance with applicable study requirements.
- Compare participant visit documentation against study protocols, CRF Completion Guidelines, laboratory manuals, pharmacy manuals, imaging manuals, sponsor manuals, and other study-specific guidance.
- Verify that all protocol-required procedures, assessments, and visit activities are appropriately completed and documented.
- Ensure source documentation adequately supports study data recorded within CRIO.
- Verify that the correct version of the informed consent form or reconsent form has been appropriately signed and documented.
- Maintain and update the QC Tracker with completed reviews, identified findings, and outstanding items.
Protocol and Sponsor Compliance
- Develop and maintain a thorough understanding of assigned clinical trial protocols and study-specific requirements.
- Review participant visits for compliance with protocol requirements, including visit windows, eligibility criteria, required procedures, assessments, and follow-up requirements.
- Identify documentation that is missing, incomplete, inconsistent, or not compliant with protocol or sponsor requirements.
- Identify potential protocol deviations and escalate findings in accordance with established processes.
- Ensure clinical research documentation aligns with applicable sponsor guidance and study-specific requirements.
Safety and Endpoint Review
- Review documentation related to Adverse Events (AEs), Serious Adverse Events (SAEs), and other protocol-defined safety events.
- Verify that safety events are appropriately documented in accordance with protocol and study requirements.
- Recognize potential safety events that may require additional review, follow-up, or reporting.
- Review documentation related to protocol-defined clinical endpoints and confirm adequate source documentation supports reported events.
- Identify missing, incomplete, or inconsistent safety and endpoint documentation and communicate findings for follow-up.
QC Documentation and Communication
- Clearly and accurately document quality control findings.
- Communicate QC findings to Clinical Research Coordinators and other designated research staff in a timely and professional manner.
- Provide clear, actionable feedback regarding documentation deficiencies and compliance concerns.
- Track identified QC findings through correction and resolution.
- Follow up on outstanding findings and escalate unresolved or significant quality concerns when appropriate.
- Collaborate effectively with U.S.-based clinical research teams, Quality, and Clinical Operations staff.
Required Qualifications
- Minimum of 3 years of clinical research experience in a role such as Senior Clinical Research Coordinator, Clinical Research Quality Control Specialist, Clinical Research Associate, Site Management professional, or another position involving significant clinical trial documentation review.
- Demonstrated experience reviewing clinical research source documentation and participant records.
- Strong knowledge of Good Clinical Practice (ICH-GCP) guidelines and clinical research documentation standards.
- Ability to independently read, interpret, and apply complex clinical trial protocols.
- Knowledge of Adverse Event and Serious Adverse Event documentation and reporting requirements.
- Understanding of CRF Completion Guidelines and sponsor documentation requirements.
- Proficiency in medical terminology.
- Strong written English communication skills.
- Strong critical thinking, analytical, and problem-solving abilities.
- Exceptional attention to detail and organizational skills.
- Ability to manage multiple studies, priorities, and deadlines in a remote work environment.
- Proficiency with Microsoft Office applications.
Preferred Qualifications
- Experience using CRIO or another electronic source documentation, CTMS, or clinical trial management system.
- Previous experience conducting quality control or quality assurance reviews within a clinical research site, site network, CRO, or similar clinical research environment.
- Experience working remotely with clinical research teams located in the United States.
- Experience reviewing documentation across multiple clinical trials, therapeutic areas, or research sites.
Performance Expectations
The successful candidate will be expected to:
- Complete assigned QC reviews accurately and within established timelines.
- Maintain the QC Tracker and other required quality documentation daily.
- Communicate QC findings promptly, clearly, and professionally.
- Effectively identify documentation deficiencies, potential protocol deviations, safety reporting concerns, and endpoint documentation gaps.
- Follow identified findings through correction and resolution.
- Consistently ensure clinical research documentation reflects study protocol requirements, sponsor guidance, and applicable quality standards.
- Maintain confidentiality and appropriately handle sensitive clinical research and participant information.
Work Schedule
This is a full-time remote position based in India. The selected candidate must be able to maintain a work schedule that provides sufficient overlap with U.S. Eastern Time business hours to support timely communication, collaboration, and resolution of quality control findings. 6:00 am-3:00 pm EST
