Quality Specialist (Clinical Research QC Reviewer)
Position: Quality Specialist
Department: Clinical Operations
Employment Type: Full-Time Contractor
Schedule: Monday – Friday during Central Standard Time (CST) business hours
Location: Remote
Position Summary
The Quality Specialist is responsible for conducting quality control reviews of participant visits and source documentation within the CRIO eSource system. This role ensures that clinical documentation is complete, accurate, protocol-compliant, and aligned with Good Clinical Practice (GCP), ALCOA principles, and our clients quality standards.
This position requires an extremely detail-oriented individual who can identify inconsistencies, documentation gaps, and potential compliance concerns before they impact study quality. The ideal candidate has previous experience as a Clinical Research Coordinator (CRC), Regulatory Specialist, or clinical research quality professional and can quickly adapt to established quality review processes.
Responsibilities
Responsibilities may include, but are not limited to:
- Review completed participant visits within the CRIO eSource platform using established quality control processes.
- Verify that all protocol-required procedures, assessments, and documentation have been completed accurately and appropriately documented.
- Review source documentation to ensure compliance with study protocols, sponsor expectations, site SOPs, and applicable regulations.
- Evaluate documentation against ALCOA and ALCOA+ principles to ensure data integrity standards are maintained.
- Identify missing documentation, inconsistencies, protocol deviations, transcription errors, and potential GCP concerns.
- Complete standardized QC Checklists to ensure consistency across studies and sites.
- Document findings thoroughly and objectively within designated tracking systems.
- Escalate significant quality findings according to established procedures.
- Collaborate with site personnel to communicate findings and support timely resolution.
- Monitor corrective actions and follow-up activities as assigned.
- Support continuous improvement initiatives designed to enhance quality and inspection readiness across the organization.
- Maintain confidentiality and adhere to all client and UniTriTeam policies and procedures.
Qualifications
Education
- Associate's degree or Bachelor's degree in a healthcare, life sciences, nursing, or related field preferred.
- Equivalent clinical research experience may be considered in lieu of formal education.
Experience
- Minimum three (3) years of clinical research experience required.
- Previous experience as a:
- Clinical Research Coordinator (CRC),
- Regulatory Specialist,
- Clinical Research Associate (CRA), or
- Similar clinical research role with direct source documentation responsibilities.
- Strong understanding of:
- Good Clinical Practice (ICH-GCP),
- Protocol compliance,
- Protocol deviations,
- Source documentation standards, and
- ALCOA/ALCOA+ principles.
- Previous experience reviewing source documentation required.
- Prior experience conducting Quality Control (QC) or Quality Assurance (QA) reviews within clinical research is strongly preferred.
- Experience supporting sponsor audits or regulatory inspections is preferred.
- Experience with CRIO or other eSource platforms is preferred.
Knowledge, Skills, and Abilities
- Extreme attention to detail with the ability to identify even minor discrepancies within clinical documentation.
- Strong organizational skills with the ability to prioritize multiple assignments.
- Excellent critical thinking and problem-solving abilities.
- Ability to interpret study protocols and apply protocol requirements appropriately during reviews.
- Strong written and verbal communication skills.
- Ability to work independently while maintaining a high level of accuracy and consistency.
- Comfortable working within a structured, checklist-driven environment.
- Demonstrated commitment to participant safety, data integrity, and quality.
Why UniTriTeam?
At UniTriTeam, we're passionate about supporting organizations that are transforming healthcare through clinical research. We believe great people deserve meaningful work, flexibility, and leaders who genuinely care about their success.
Perks of Joining UniTriTeam
- 100% Remote Opportunity
- Work with innovative clients making a difference in healthcare and research.
- Join a collaborative and supportive global team environment.
- Exposure to a variety of therapeutic areas and research programs.
- Opportunities for professional development and continued growth.
- Leadership that values transparency, accountability, and communication.
- The ability to make a direct impact on the quality and integrity of clinical research.
About UniTriTeam
UniTriTeam is a women-owned global workforce solutions organization specializing in clinical research operations, technology, and strategic staffing support. We partner with sponsors, CROs, site networks, and research organizations to deliver exceptional talent and innovative solutions that improve efficiency, strengthen compliance, and accelerate clinical trial execution.
Our team members are collaborative, accountable, and committed to delivering excellence while maintaining the highest standards of professionalism and integrity.
