Quality Control

Job Summary:

The Quality Control Specialist for Clinical Research is responsible for reviewing source documents against clinical trial protocols to ensure data accuracy, completeness, and compliance with regulatory requirements. This role is critical in verifying that study activities are conducted according to the protocol and ensuring the integrity of clinical trial data.

Key Responsibilities:

Source vs. Protocol Review:

• Perform comprehensive reviews of source documents to ensure alignment with clinical trial protocols.
• Verify that clinical assessments, procedures, and data capture are conducted and documented according to protocol requirements.
• Ensure that protocol-specified inclusion/exclusion criteria, study visits, and procedures are accurately documented in source records.
• Identify protocol deviations and discrepancies between source documents and electronic case report forms (eCRFs).

Data Quality Assurance:

• Conduct source data verification (SDV) to ensure accurate and reliable data reporting.
• Ensure the timely resolution of discrepancies by working closely with clinical research coordinators (CRCs) and investigators.
• Track and document findings, including missing data, protocol violations, and inconsistencies.

Compliance Monitoring:

• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
• Maintain detailed records of quality control findings and corrective actions.
• Provide input and recommendations for improving data collection and source documentation practices.

Documentation and Reporting:

• Maintain audit-ready documentation of quality control activities and findings.
• Prepare and present QC reports to clinical and project management teams.
• Support audit and inspection preparation by verifying the completeness of source documentation.

Training and Collaboration:

• Provide guidance to research teams on best practices for source documentation and protocol adherence.
• Assist in training site personnel on documentation requirements and quality standards.
• Collaborate with clinical teams to implement corrective and preventive actions (CAPAs) for identified issues.

Qualifications:

Education:

• Bachelor’s degree in Life Sciences, Nursing, Clinical Research, or related field (preferred)

Experience:

• 2-4 years of experience in clinical research quality control or data verification
• Strong understanding of clinical trial protocols, source documentation, and regulatory requirements

Skills:

• Excellent attention to detail and problem-solving skills
• Ability to identify and document data discrepancies and protocol deviations
• Strong organizational and time management skills
• Proficiency with clinical data management systems and electronic data capture (EDC) systems
• Effective communication skills for reporting findings and collaborating with research staff

Preferred Certifications:

• Certified Clinical Research Professional (CCRP) or equivalent
• Good Clinical Practice (GCP) Certification

Job Type: Full-time

Pay: $18.00 - $25.00 per hour

Expected hours: 40 per week

Benefits:

• Flexible schedule
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekends as needed

Work Location: In person

Salary : $18 - $25