Research Analyst

• Develop clinical trial budgets, including review of protocols and relevant documents to ensure that appropriate costs and allocation of institutional resources are fully captured in the budget.
• Work in collaboration with ancillary teams, departments, investigators, research staff, supporting administration, and sponsors/funding agencies to create complete, comprehensive, accurate and timely budgets.
• Ensure appropriate research rates are applied to study budgets.
• Independently develop, negotiate, and finalize budgets of moderate complexity with sponsors, academic sites, and other extramural funding sources to reach an agreement on budget and payment terms.
• Submit and maintain the budget and other financial information into OnCore Clinical Trial Management System (CTMS) to maintain proper reimbursement and revenue integrity.
• Perform pre-award quality assurance to verify completion of required elements prior to Medicare Coverage Analysis.
• Communicate and meet with stakeholders to facilitate ongoing budget discussions and provide updates to relevant parties.
• Use advancing knowledge to develop and disseminate clinical research education as needed in accordance with federal regulations, institutional policies, and specific protocol requirements.
• Apply knowledge of clinical research to provide recommendations and direction to clinical research teams to ensure budgetary compliance throughout all phases of the Clinical Trial Financials Lifecycle.
• Develop and support the formulation of program policies, procedures, and resources to establish and enhance clinical trial financials workflows.
• Provide excellent customer service while maintaining accurate results in a fast-paced, deadline-driven team environment.
• Engage in special projects and ad hoc duties as a member of the administrative team.

Clinical Trials Budget Specialist II

• Translates business requirements into business solutions;
• Acts as liaison between departmental leaders, staff and information technology staff to design and configure business solutions to ensure business requirements have been met.
• Works closely with stakeholders to define business requirements and with technical staff to develop solution alternatives and actively participates in defining objectives to support changing business needs and availability.
• Coordinates IT troubleshooting and day to day activities within the department to ensure seamless and minimal downtime of hardware, software and reporting requirements.
• May manage small to mid-sized projects/tasks and represent the department on larger enterprise-wide project teams.
• Creates and maintains project schedules by developing project plans and specifications, estimating time requirements, establishing deadlines, monitoring milestone completion, tracking all phases of the project product/service lifecycle, providing timely reporting of issues that impact project progress, coordinating actions, and resolving conflicts.
• Coordinates and conducts project team meetings regularly to review project deliverables and deadlines.
• Has knowledge and experience in the various techniques to elicit, analyze and communicate requirements within assigned functional areas.
• Establishes test plans, test cases and executes testing.
• Assists with end user training.
• Recommends information technology solutions to meet business needs and coordinates the planning, development, and implementation of these solutions.

Business Analyst II

• Conducting comprehensive Medicare Coverage Analysis for new studies and amendments, ensuring alignment with regulatory requirements
• Building out Protocol Cost Assessments (PCAs) based on the Schedule of Activities (SOA) outlined in study protocols
• Completing detailed justifications to support payment determinations for services and items
• Leading budget negotiations for protocol amendments
• Monitoring and responding to the finance general email inbox

Senior Clinical Research Financial Analyst

• Contribute to study design and methodology development
• Develop innovative approaches, frameworks and solutions to client problems
• Deliver project outputs that meet established quality standards, timelines, and budget requirements
• Conduct structured literature reviews and targeted secondary research to support RWE initiatives
• Participate in qualitative research activities, including patient interviews, to generate actionable healthcare insights
• Analyze and interpret qualitative and quantitative ‘real-world’ data for deliverables
• Conduct workshops and moderate discussions
• Present results to external clients
• Contribute to the development of: Study protocols, Technical reports, Manuscripts and scientific posters, Client presentations
• Develop and format materials using PowerPoint, Word, and Excel
• Summarize and synthesize complex clinical and outcomes data into clear, structured findings
• Support retrospective and prospective real-world studies under senior guidance
• Demonstrate openness to leveraging emerging technologies, including AI-enabled tools, to improve efficiency, analytical rigor, and personal productivity

Senior Research Associate

• Oversee monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.
• Provide experienced leadership to a team of Clinical Research Associates involved in clinical studies executed at the sites.
• Direct supervision/line management of CRA staff and contractors in accordance with Celerion policies and applicable regulations.
• Interview, hire, and conduct onboarding training for new staff.
• Prepare and implement function-specific training programs and ensure adherence to Celerion’s procedures and guidance documents.
• Assign staff members to clinical projects and monitor staff workload.
• Ensure timely submission of timesheets and expense reports by staff.
• Develop, mentor, manage and coach CRA staff to progress their skills.
• Perform annual appraisals, define performance objectives and advocate individual career development.
• Serve as escalation line for direct reports including troubleshooting and issue escalation.
• Generate action plans and provide oversight to optimize monitoring services.
• Maintain a positive, results-oriented work environment and model teamwork.
• Support day-to-day execution of monitoring services for ongoing projects.
• Ensure deliverables of the CRAs assigned to the projects are met on time within quality and budget parameters.
• Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary.
• Participate in audits and inspections, including preparation activities.

Lead, Clinical Research Associate

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
• Demonstrates diligence in protecting the confidentiality of each subject/patient
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Assesses site processes as per the Clinical Monitoring/Site Management Plan (CMP/SMP)
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
• Supports subject/patient recruitment, retention and awareness strategies
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met

Clinical Research Associate – Full-Service

• Conducting thorough research into an individuals’ background using a variety of tools, such as databases and public records
• Gathering information, analyzing data, and compiling this information to be entered into a final report
• Processing searches related to background screening reports
• Ensuring all searches are processed and reported according to state and federal laws as outlined in AccuSourceHR’s reporting guidelines
• Ensuring all searches are processed according to client guidelines
• Retrieving public records information and entering said information into our platform
• Analyzing information and comparing data sets to confirm matching identifiers
• Performing other duties as assigned
• Meeting or exceeding minimum standard service requirements

Research Specialist

• Support the Oncology, Alzheimer's, Orthopedic, and University of Arizona's Research initiatives.
• Read and understand clinical trial protocols, budgets, and related documentation.
• Build research studies within our Clinical Trials Management System for use by clinical staff and financial teams.
• Manage high-quality calendar builds, accurate financial entry services for site clients.
• Collaborate with internal Banner Research teams and site clients to ensure billing determinations, sponsor budget, and clinical trial agreement are congruent with the clinical trial protocol and site client requirements.
• Translate protocol requirements into structured calendars and manage site clients with exceptional customer service.
• Perform QA process for study builds from team members and document reviews with new team members for study build accuracy.
• Collaborate with study teams to validate visit calendars and study procedures.
• Answer questions regarding study builds and provide timely resolution or escalation.

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