• Accountable for regional study delivery with appropriate inspection-ready quality, within agreed timelines and budget. • Lead the regional clinical operations team and act as point of escalation for issue resolution. • Ensure alignment of regional deliverables with overall study goals. • Collaborate with key stakeholders in the region and provide regular updates on study progress. • Generate, manage, and maintain high-quality study start-up and recruitment timelines for the region. • Ensure timely availability of local adaptations of global study documents and submissions to regulatory authorities. • Work closely with CRAs in the region to ensure proper study execution at sites. • Handle escalated issues or problems with sites in the region. • Monitor regional study activities for compliance with the study protocol, SOPs, and ICH-GCP.

• Participates in the development of global study strategic feasibility proposals in partnership with regional strategic feasibility teams and cross-functional stakeholders • Serves as a feasibility point of contact for assigned studies, programs, or workstreams and liaises cross-functionally • Promotes consistent use of agreed data, tools, templates, and processes across regions • Provides operational feasibility insights to inform study design considerations and optimization discussions • Maintains strong working knowledge of feasibility tools, technologies, databases, and platforms • Supports modelling of strategy options for the study using relevant internal and external data assets • Contributes feasibility insights to strategic planning meetings, training calls, study kick-off meetings, and ongoing study team meetings • Collaborates with Data Science & Operational Excellence, Clinical Systems & Innovation in the development of feasibility tools, systems and platforms • Determines risk/mitigation planning to study feasibility or recruitment and retention of participants • Performs root cause analysis and recommends mitigation steps to address feasibility-related roadblocks

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. • Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. • Responsible for assuring that data for statistical analyses are complete, accurate and consistent. • Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions. • Responsible for validity of analysis and explore alternative analysis strategies as needed. • Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation. • Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings. • Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency. • Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians. • Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Role Description 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. - 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 - 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. - 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. Requirements - 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. Benefits - 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.