Role Description The Clinical Informaticist II applies advanced knowledge at the intersection of clinical practice, information science, and healthcare technology to optimize the use of clinical information systems and improve patient outcomes. This role supports the assessment of information and knowledge-based needs of healthcare professionals and patients, refines clinical processes, and leads or contributes to the development, implementation, and continuous improvement of clinical information systems including electronic health records (EHR) and clinical decision support (CDS) tools. The position operates in a government contracting environment supporting complex federal healthcare delivery systems. Please note this position is contingent upon award (July/Aug 2026). Key Responsibilities - Assess information and knowledge-based needs of healthcare professionals and patients to inform system design, configuration, and optimization activities. - Characterize, evaluate, and refine clinical processes to enhance efficiency, accuracy, and quality of care delivery. - Develop, implement, and refine clinical decision support (CDS) systems to promote evidence-based clinical practice. - Lead or participate in procurement, customization, development, implementation, management, evaluation, and continuous improvement of clinical information systems, including EHR and order-entry systems. - Translate clinical requirements into functional and technical specifications for health IT development and configuration teams. - Conduct gap analyses, workflow assessments, and usability evaluations to identify opportunities for system enhancement. - Collaborate with clinical staff, IT teams, and program management to ensure system implementations meet clinical and operational objectives. - Develop training and change management materials to support end-user adoption of clinical information systems. - Monitor post-implementation performance and recommend enhancements to achieve intended clinical and operational outcomes. - Prepare written reports, presentations, and recommendations for government clients and senior stakeholders. Qualifications - Master's Degree in Clinical Informatics, Biomedical Informatics, Health Informatics, Nursing Informatics, or a related clinical or health information science field. - Minimum of 5 years of experience in clinical informatics or a directly related discipline. - Demonstrated experience supporting the implementation or optimization of clinical information systems, including EHR platforms. - In-depth knowledge of clinical workflows, healthcare delivery processes, and patient care environments. - Experience with clinical decision support (CDS) design, build, and governance. - Proficiency with electronic health record (EHR) systems such as VistA, Cerner Millennium, Epic, or equivalent platforms. - Familiarity with clinical terminology standards including SNOMED CT, LOINC, ICD-10, CPT, and RxNorm. - Knowledge of health information exchange standards including HL7 v2, HL7 FHIR, and CDA. - Strong analytical skills with the ability to evaluate clinical system performance and recommend evidence-based improvements. - Excellent written and verbal communication skills, with the ability to engage both clinical and technical audiences. - Familiarity with quality improvement methodologies (e.g., Lean, Six Sigma, PDSA cycles) as applied in healthcare settings. Preferred Qualifications - Experience working with the Veterans Health Administration or a similar federal health agency (CDC, CMS, DHA, HHS, etc.). - Active security clearance or ability to obtain one. - American Medical Informatics Association (AMIA) certification (e.g., FAMIA, ABPM Board Certification in Clinical Informatics). - Clinical background or licensure (e.g., RN, MD, PharmD, or allied health credential). - Familiarity with VistA, CPRS (Computerized Patient Record System), and/or VA's EHR Modernization (EHRM) program with Cerner/Oracle Health. - Experience with Agile or SAFe methodologies in a federal health IT program. - Knowledge of the VA/DoD health information sharing environment and Joint Legacy Viewer (JLV). - Experience developing or evaluating clinical quality measures aligned with CMS, Joint Commission, or VA performance frameworks. Benefits - Health, Dental, and Vision Plans - Short Term Disability / Long Term Disability / Life Insurance / Accidental Death and Dismemberment - Health Savings Account - Unlimited Paid Time Off - 11 Federal Holidays Off - 401k Company Description We are committed to diversity, inclusion, and accessibility. We are an Equal Opportunity Employer in all aspects of employment and do not discriminate for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. 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• Serve as a day-to-day operational point of contact for assigned CROs and vendors, tracking study deliverables and timelines and flagging risks or delays to clinical operations leadership. • Review CRO-generated study documents for completeness and quality, including monitoring visit reports, site correspondence, protocol deviations, and TMF entries. • Support the coordination of study startup activities, including site activation tracking, regulatory document collection, and vendor kick-off preparation. • Maintain and update study trackers, timelines, and action logs; ensure cross-functional teams have visibility into study status and open items. • Attend and support cross-functional study team meetings; document meeting minutes, track action items, and follow up on outstanding deliverables. • Track and triage protocol deviations reported by CROs; coordinate with vendors and internal teams to ensure timely documentation and resolution. • Support safety reporting coordination, including tracking SAE/SUSAR notifications and ensuring timely distribution to sites and relevant stakeholders in line with vendor responsibilities. • Monitor TMF completeness and support inspection readiness activities, working with CROs to resolve filing gaps and maintain document quality standards. • Assist with IRB/IEC tracking across study sites, including monitoring approval status for amendments and annual renewals submitted by the CRO. • Compile and distribute enrollment, site performance, and operational metrics to clinical operations leadership on a regular basis. • Contribute to data reviews as needed, and track data cleaning progress performed by CRO. • Review and track monitoring visits and monitoring visit reports performed by CRO to ensure high quality and adherence to the monitoring plan. • Support vendor invoice review and budget tracking by reconciling CRO invoices against contracted activities and flagging discrepancies. • Coordinate data reconciliation activities at key study milestones in collaboration with data management and the CRO. • Support the onboarding of CTAs joining the study team and serve as a resource for day-to-day study questions.

• Responsible for performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements. • Performs essential document collection and review for site start up and initiates in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices. • Demonstrates ability to successfully lead and mentor CTS staff, take on high level tasks as delegated by Project Manager/Functional Manager, and escalate and mitigate risk as appropriate. • Manage Regulatory and Institutional Review Board (IRB) Activities: Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission. • Conduct regulatory packet submissions to clients for site approval and drug release. • Create and review project planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan. • Train sites on their continued contractual, regulatory, and legal obligations. • Evaluate sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study. • Manage site relationships to ensure positive interactions through routine site contact. • Ensure sites meet subject safety reporting regulations: subject safety information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB. • Track study activities, milestones, document receipt, and payment status in CTMS.

Develop and execute site engagement strategies, build strong relationships with clinical trial sites, manage study challenges, and collaborate with internal teams to ensure successful clinical trial execution and compliance.