• 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.

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. Responsibilities - 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. 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. 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. Company Description 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.

Role Description Medpace is growing quickly and we are seeking a Clinical Research Associate to join our team in Alberta or British Columbia Canada. This is a home-based position in Alberta or British Columbia Canada. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence and receive customized, expedited training, and efficient onboarding to familiarize experienced CRAs with Medpace systems. Responsibilities - Conduct pre-study, initiation, monitoring, and closeout visits for research sites according to Medpace/Sponsor SOPs and GCP; - Maintain ongoing site correspondence and site files; - Complete visit reports and maintain study-related databases; - Oversight and interaction with clinical research sites; - Review of patient charts and clinical research data. Qualifications - Bachelor’s degree in science from an accredited university; - At least 1 year as a Clinical Research Associate or Clinical Research Coordinator; - Bilingual in English and French; - Thorough knowledge of the methodology related to the conduct and monitoring of clinical trials per ICH E-6 guidelines and per Part-C, Division 5 of the Health Canada Food and Drug regulations; - Excellent interpersonal, written and verbal communication skills in English and French; - Strong attention to detail and organization skills; - Highly motivated, independent, flexible; - Ability to travel between 60-80%; - Ability to prioritize workload to meet timelines across multiple studies; - Proficient in Microsoft Office. Benefits - Competitive bonus plans including Resourcing Bonus (following training completion and successful assignment to studies) and Yearly Travel Incentives; - Voluntary retirement scheme; - Home office furniture allowance, mobile phone and hotspot for internet access anywhere; - In-house travel agents, reimbursement for airline club and TSA pre-check; - Customized PACE training program based on your experience and therapeutic background and interest; - User friendly CTMS with electronic submission and approval of monitoring visit reports; - Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; - National assignments with average of 2 protocols; - In-house administrative support for all levels of CRAs; - Opportunities to work with international team of CRAs; - Low turnover rates for CRAs; - No metric for minimum required days on site per month; - Flexible work hours across days within a week; - Opportunity for CRA leadership positions – Lead CRA, CRA Manager; - Many additional perks unmatched by other CROs! Company Description Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.