Clinical Research

• 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/CeMs) 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
• 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
• 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
• 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 or may coordinate clinical activities for a team of CTMs across a portfolio of projects
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation

Clinical Trial Manager

• Support the classification of new variants within established guidelines, by examining laboratory and patient data, and evaluating scientific literature to provide evidence for each variant’s role in disease and/or treatment.
• Support the reclassification of variants.
• Prepare and present both external and internal data to classify variants.
• Work with all departments to ensure the highest quality clinical test results with unparalleled accuracy for all patient samples in a timely manner including the identification and resolution of issues.
• Participate in clinical genomics projects to implement, validate, and test new processes for variant classification.
• Responsible for one or more activities related to the classification of variants such as pipeline improvements, classification procedure, autoclassification, or a project involving multiple teams across the enterprise.
• Maintain familiarity with the field’s concepts, practices, and procedures.
• Conduct other duties delegated or defined by the CLIA lab director.
• Occasionally work a variable schedule, including early mornings, evenings, weekends, and/or holidays.

Lead Clinical Genomics Scientist

• Manage Grant Accounts for Federal, State, Foundations, Industry Sponsors, and Internally Funded sponsors - including but not limited to creating grant awards; Manage invoicing, revenue generation, expenditure reports, Facility and Administration Costs, and grant close out.
• Responsible for grants reports for revenue and expenditures, invoice management, budget to actual analysis - for both UH internal and external customers
• Grants Invoicing, Grants to GL Account Reconciliation, Other tasks as assigned to meet the goals and mission of CCRT
• Performs other duties as assigned. Complies with all policies and standards. For specific duties and responsibilities, refer to documentation provided by the department during orientation. Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients.

Grant Accountant I

• Drive clinical innovation by identifying emerging customer needs
• Partner with clinicians and researchers to co-create new ideas and technologies
• Shape CT business strategy through clinical prototypes and innovation roadmaps
• Build and lead strategic collaborations with clinical experts and research partners
• Generate clinical evidence through research partnerships and sponsored trials
• Serve as a clinical thought leader by providing market insights and communicating value propositions

Clinical Scientist – Computed Tomography

• Work collaboratively with a team of biostatisticians, data managers, data entry personnel and programmers to accomplish research objectives
• Lead the establishment and maintenance of computerized databases for internally and externally funded research
• Provide statistical expertise to investigators and researchers
• Coordinate the training and development of statistical personnel
• Track project team progress and adherence to deadlines
• Review and provide feedback on the design and conduct of randomized and non-randomized clinical trials or retrospective studies
• Develop areas of special interest, pursue independent topics for presentation or publications, and apply innovative statistical analyses to specific research projects for which standard methods of analysis are not appropriate
• Consult with investigators on methods and procedures for implementing studies and clinical trials

Lead Biostatistician

• Serve as the team leader for a collaborative group of biostatisticians, data managers, data entry personnel and programmers
• Provide statistical expertise in the design and conduct of clinical trials and research studies
• Lead multiple projects or complex components of large-scale studies simultaneously
• Oversee statistical programming, database management and data analysis activities
• Help shape departmental policies and determine resources and budget needs for statistical support
• Coordinate the training and development of statistical personnel
• Participate in initiatives that advance the mission of the department

Principal Biostatistician – Team Lead

• Provides strategic input as the lead statistical subject matter expert supporting clinical research studies
• Leads or oversees statistical analyses and application of advanced research methods
• Contributes statistical expertise to research proposals, grant-supported initiatives, protocol development, and scientific publications
• Publishes research findings in recognized scientific publications

Principal Biostatistician

• publish content on external website (dcri.org) and intranet (Pulse) using content management systems (Drupal and SharePoint, respectively)
• create graphics for social media, external websites, and intranet
• determine requirements for instructional audiovisual media and coordinate production of slide series, films, videotapes and other media materials for use
• works both independently and collaboratively with internal Shared Services department, Production Designers and Marketing Managers on a wide mix of creative initiatives
• manage calendar of DCRI’s scientific conferences, researching Duke-related presentations at each show
• for scientific conferences at which DCRI has an exhibit booth, coordinate the marketing collateral needed for the booth
• prepares layouts, designs, artwork and formats for use in publication and/or exhibition design
• contribute to editorial planning by suggesting content ideas, target channels and audiences, and appropriate project timelines
• compile weekly internal newsletter in MS Outlook
• create quarterly external-facing newsletters using Constant Contact
• occasional content development for DCRI-owned external and internal channels
• serve as backup manager of DCRI’s social media channels (Twitter and LinkedIn)
• assist in the shooting and production of video and audio projects
• develop a broad knowledge of research conducted at the DCRI

Clinical Research Comm Specialist III

• Works to obtain and maintain a current understanding of Federal, State and local laws, regulations and guidelines governing human subject research (15%)
• Reviews human research protocol submissions to ensure that the UHCMC clinical research activities are conducted in compliance with IRB policies, institutional SOPs and international, federal, state, and local rules, regulations and ethical principles regarding the use of human subjects in research. (30%)
• Coordinates IRB meetings including preparation of the agenda and materials in addition to recording medical and ethical issues discussed to ensure accurate documentation of IRB determinations. (25%)
• Functions as a liaison within and between the IRB committees, investigators and their designees, and Center for Clinical Research and Technology (CCRT) staff. (15%)
• Participates in special projects. (15%)
• Performs other duties as assigned.
• Complies with all policies and standards.

IRB Specialist I, Clinical Research

• Coordinate and facilitate the clinical trial data for participants enrolled in clinical research studies conducted by principal investigator(s)
• Assist and complete case report forms entry, review and abstraction required to conduct clinical research
• Provide timely and professional ongoing data entry of clinical trial data by identifying errors and inconsistencies
• Assure that the integrity and quality of the clinical research trial is maintained

Clinical Research Data Specialist I

• Contribute to clinical development of plan preparation
• Review of study protocol and preparation of statistical methodologies
• Programming of study analysis, review of study results and preparation of statistical methods section for clinical / statistical reports
• Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis
• Communicate statistical results to medical writing personnel to ensure accurate interpretation

Virtual Biostatistician – PhD Statistics/Biostatistics

• Provides advanced financial, accounting, and operational support by managing complex fiscal activities.
• Serves as a key resource to departmental leadership, faculty, and staff.
• Oversees budgeting, forecasting, financial reporting, procurement, and internal controls.
• Evaluates departmental fiscal processes, identifies opportunities for improvement, and implements changes.

Senior Financial Operations Analyst – Center for Clinical Research Management

• Join our Clinical Surveillance & Training (CST) team as a Clinical Scientist
• Lead Rater Training Excellence: Design and deliver scientifically grounded rater training programs to ensure consistent, high-quality endpoint assessment and reduce variability across sites
• Drive Patient Eligibility Quality: Perform comprehensive eligibility reviews, providing a second level of scientific oversight to confirm appropriate patient selection and minimize protocol deviations and safety risks
• Deliver Data-Driven Insights: Analyze clinical and endpoint data to identify trends, variability, and potential risks—translating findings into actionable insights that improve study execution
• Shape Protocol Strategy: Partner with sponsors and study teams to review protocols and provide expert guidance on endpoint strategy, scale selection, and study design feasibility
• Act as a Scientific Leader: Collaborate cross-functionally with clinical operations, medical, and sponsor teams to proactively identify risks and deliver solutions that protect study integrity

Clinical Scientist – Clinical Surveillance & Training, Clinical Psychologist/Neuropsychologist

• Develop medical plans and coordinates with Medical Directors
• Perform medical reviews of data listings
• Author and review medical data queries
• Manage project scope and quality of deliverables
• Collaborate with study team members to identify risks

Clinical Scientist – Immunology, Ulcerative Colitis, Crohn’s Disease, Rheumatology

• Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Reviews SAS annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.

Principal Biostatistician, RWE – PASS Experience

• Partner cross-functionally with Project Management, Business Development, Commercial Finance, and Legal to ensure financial risks are identified and addressed early in the study lifecycle
• Establish and maintain operating mechanisms that improve visibility into study financial performance, including budget tracking, variance analysis, and risk forecasting
• Translate financial insights into actionable recommendations that influence operational and commercial decision-making
• Lead continuous improvement initiatives to enhance financial processes, reduce cycle times, and improve data quality and reporting consistency
• Drive accountability across stakeholders for financial performance
• Coordinate and oversee sponsor financial audits, ensuring compliance with contractual terms, regulatory expectations, and audit readiness standards
• Build, lead, and develop a high-performing, globally distributed finance team

Clinical Research jobs in Ohio

See all jobs on JobTailor