Clinical Research

• Knowledgeable in regulatory and institutional policies and processes
• Is responsible for all aspects of managing and documenting Investigational Product (IP)
• Serves as the primary liaison with sponsors, IDS, and other parties as necessary
• Prepares for and provides support for study monitoring and audit visits
• Maintains participant level documentation for all studies
• Employ strategies to maintain retention rates
• Screens participants for complex studies
• Develops or helps develop SOPs
• Conducts activities for study visits in compliance with the protocol
• Prepares for, coordinates, and actively participates in site visits

Clinical Research Coordinator

• Ability to phone screen patients or caregivers in caring and empathetic manner.
• Document patient information correctly in the computer database.
• Schedule/reschedule patient screen and prescreen appointments.
• Manage incoming calls from patients interested in taking part in research studies.
• Evaluate eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with site clinic staff.
• Learn and maintain knowledge regarding clinical research studies including inclusion and exclusion criteria for different studies.
• Record contact status of patients and document information in the database.
• Review, call and update sponsor patient portals as needed.
• Perform all other duties that may be requested or assigned.

Clinical Research Patient Recruiter

• Develop statistical methodologies, protocols, and sample size calculations for pre-market and post-market clinical studies.
• Plan methods to collect data and develop or review case report forms to ensure compatibility with plan design.
• Evaluate reliability and validity of source information, apply weightings to raw data, and organize results in form appropriate to software requirements.
• Designs clinical trials, analyzes study data to validate device safety and efficacy, and creates Statistical Analysis Plans (SAPs).
• Perform advanced statistical analyses using appropriate methodologies.
• Interpret results and provide strategic insights.
• Review clinical literature and analyze Real-World Evidence (RWE) to set performance goals.
• Write reports summarizing trial outcome statistics, indicating sources of data and limits on reliability and usability, for in-house, regulatory and publication target audiences.
• Prepare statistical reports for regulatory submissions (FDA, CE Mark, other regulatory authorities like TUV) and address regulatory inquiries.
• Performs analysis and generates visual/tabular data for scientific presentations and publications.
• Collaborate with cross-functional team members (clinical affairs, data management, pre-clinical and R&D engineers) to define endpoints, analyze safety reporting, and prepare for submissions.to ensure data integrity and accurate analyses.
• Develop statistical tables and data summaries as needed.
• Review project database structures, edit checks and data management coding conventions.
• Ensure compliance with industry standards and guidelines.
• May attend relevant scientific and/or medical meetings.
• Support publication of study findings.

Senior Biostatistician

• Handles administrative activities generally associated with the conduct of clinical trials
• Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms
• Provides guidance to less experienced staff
• Interfaces with research participants, determines eligibility and consents study participants according to protocol
• Approves orders for supplies and equipment maintenance
• Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires
• Supervises collection of study specimens and processing
• Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed
• Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors
• Prepares regulatory submissions
• With appropriate credentialing and training may perform phlebotomy or diagnostics
• Performs related approved responsibilities as required.

Clinical Research Coordinator II

• Writes, reviews, tests, and maintains code to support analytic dataset development and statistical analyses, ensuring accuracy, efficiency, and reproducibility.
• Implements data quality initiatives under the guidance of the Registry Lead to ensure accuracy, completeness, and reliability of datasets.
• Works closely with the Registry Lead to ensure timely completion of deliverables and adherence to project deadlines.
• Assists the Registry Lead in maintaining existing reports and developing new reports as needed.
• Produces monthly analytic data cuts, monthly reports, and quarterly reports, ensuring accuracy, consistency, and alignment with reporting requirements.
• Serves as an additional point of contact for assigned registries, proactively supporting colleagues by addressing registry-related questions on data structures, outputs, etc.
• Provides support on ad hoc projects and analyses as needed.
• Creates data pipelines for ingestion of external data sources and integration with clinical registry data to create combined datasets.
• Compiles, analyzes and reports statistical data for various projects.
• Carries out complex statistical analyses with supervision according to a statistical analysis plan.
• Assists Biostatistical Team Lead in the development of new statistical methodology for measurement and analysis of data.
• Assesses relevant literature as well as existing data, evaluates the quality of data used in reports and assists with preparation and distribution of periodic reports.
• Prepares written reports and summarizes data for investigators with minimal supervision.
• Makes original contributions to research projects, takes initiative in professional activities and beginning to be more independent in their statistical decision making.
• Closely collaborates and participates in knowledge sharing with other statistical analysts.

Biostatistician II

• Serve as the lead Clinical Research SME for the engagement, guiding all aspects of the operational assessment and change management strategy.
• Conduct in-depth interviews with clinical research staff and stakeholders across the clinical trial lifecycle to identify operational gaps, bottlenecks, communication challenges, and improvement opportunities across Oncology and Non-Oncology programs.
• Partner with executive and operational stakeholders to assess organizational readiness for change and recommend sustainable transformation strategies.
• Collaborate with the Vitalief team to design effective interview templates, assessment methodologies, and change management frameworks.
• Evaluate current-state workflows, governance structures, staffing models, and technology utilization to identify opportunities for operational alignment and standardization.
• Compare Oncology and Non-Oncology operations to identify transferable best practices and opportunities for cross-functional integration.
• Develop prioritized, actionable recommendations that address immediate operational challenges while supporting long-term scalability and organizational adoption.
• Create and present a clear transformation roadmap focused on operational excellence, stakeholder engagement, process optimization, and effective cross-system coordination.
• Provide regular project status updates to executive stakeholders, ensuring alignment, transparency, and on-time delivery of engagement milestones.
• Deliver executive-level presentations summarizing findings, recommendations, change impacts, and measurable next steps.

Clinical Research Change Management Consultant

• oversee and administer clinical research studies and associated activities
• assist with the development and management of study budgets
• assist with the review of protocol requirements and assist with the collection of impact statements needed to properly assign costs to each assessment/procedure
• provide feedback on the amount of time necessary for conduct staff to administer assessments and procedures as assigned during the budgeting process
• cooperate as necessary with the Geneva Corporate Manager to ensure that studies remain financially healthy, including but not limited to, the review of monthly budget reports as well as budget forecasts
• assist in project planning, and ensure that pre-established work scope, study protocol and regulatory requirements are followed
• recruit and coordinate research subjects, as appropriate, and serves as principal administrative liaison for the project
• oversee and coordinate the provision of administrative and staff services to investigators; develop and maintain record keeping systems and procedures
• assist with the preparation of presentations for required review and approval processes, to include public affairs office review as applicable

Senior Clinical Research Coordinator

• Working cross-functionally to conduct gap analyses in clinical evidence and recommending strategies in line with business goals
• Providing leadership for the conduct of clinical research for product approval, post-market clinical follow-up, and market adoption or development
• Ensuring research plans are scientifically valid, meeting regulatory requirements, and are conducted within ethical guidelines
• Ensuring audit readiness and participating in related activities, e.g., serving as a subject matter expert
• Setting and communicating strategy, direction, priorities, and goals in partnership with the CRMS Leadership Team
• Serving as the ENT Clinical Research representative for enterprise councils and communities of practice
• Creating and maintaining a culture of ownership and accountability
• Managing performance, developing talent, and fostering engagement and inclusion through 1:1s, feedback, coaching, and delegation
• Setting and maintaining the budget and resourcing for the clinical research program and team
• Advancing ways of working and operational efficiency, including the use of AI-enabled tools
• Communicating business and operational developments up, down, and across
• Preparing reports and presentations for internal and external stakeholders for projects and budgets, integrating information from multiple sources

Senior Clinical Research Manager

• Support end-to-end execution of clinical studies (start-up through closeout)
• Manage day-to-day study activities across sites, CROs, and vendors
• Ensure protocol adherence and high-quality data collection
• Collaborate with Medical Affairs, Quality Assurance, Regulatory Affairs, and Marketing/Market Access
• Track study budgets and forecasts
• Support Regulatory in IDE pathways and study requirements

Clinical Trial Manager

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings such as Kick Off Meeting.
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
• Ensures access and audit trail reviews are conducted as required.
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
• Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.
• Provides solutions for obstacles in protocol execution and site management.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA).
• Supports Inspection Readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
• May develop and support execution of corrective action plans at site and study level.
• Supports and completes activities to achieve data cut and lock deadlines.
• Provides feedback to line managers on staff performance including strengths as well as areas for development.
• May be assigned to larger, more complex trials.

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