Clinical Research

• 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

Operations Finance Director – Clinical Research Central Laboratory

• Provide assistance in support of the Ohio State Genomic Health community health research initiative.
• Assist with implementation and coordination of this and related studies.
• Participate in recruitment of study participants.
• Assist with collection, maintenance, & reporting of clinical research data in conjunction with the larger study team.
• Recruitment includes email invitations, phone calls with eligible and consented individuals to answer questions, and likely future in-person community recruitment events.

Clinical Research Assistant – Clinical Trials Management

• Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center (20%)
• Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees (20%)
• Coordinate and perform study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials (30%)
• Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations (20%)
• Embraces the principles and practice of leadership and professionalism in clinical research. Provides mentorship and training on the clinical trial and regulatory process to staff members (10%)
• 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.

Clinical Research Regulatory Specialist II

• Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager
• Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy
• Compile and maintain project-specific status reports within the clinical trial management system
• Interact with the internal project team, Sponsor, study sites, and third-party vendors
• Provide oversight and quality control of our internal regulatory filing system
• Provide oversight and management of study supplies
• Create and maintain project timelines
• Coordinate project meetings and produce quality minutes

Associate Clinical Trial Manager – Cardio, Renal, GI, Metabolic

• Assist in coordinating studies by preparing personnel and materials, protocols, informed consents, amendments, and other necessary documents for review by the IRB and Sponsor.
• Assemble lab kits and/or gather supplies.
• Collect and label samples as instructed and deliver or process samples in accordance with the protocol.
• Ensure specimens are properly logged, handled and stored.
• Follow direction of clinical research coordinator or others involved in the clinical research project work.
• Assist other staff members and coordinators to implement studies.
• Maintain inventory of supplies and equipment.
• Operate standard laboratory and research study equipment, if applicable.
• Troubleshoot and correct erroneous results or problems with equipment.
• Identify regulatory activities to be completed and take the initiative to complete them.
• Assist in maintaining up-to-date and accurate written and electronic records and files.

Clinical Research Coordinator II – Behavioral Medicine, Clinical Psychology

• Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials; how drugs, devices and biologicals are developed and regulated.
• Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study.
• Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.
• Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators; understands teamwork skills critical to responsible conduct of clinical research.
• Embraces the principles and practice of leadership and professionalism in clinical research.

Clinical Research Regulatory Specialist I

• Support Safety Analytics with ADaM /TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables
• Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display
• Provide ADaM /TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries
• Interrogating root cause of issues identified during ADaM /TFL/Interactive package review

Senior Clinical Pharmacology/Biopharmaceutical Biostatistician

• Serves as lead resource in the execution of assigned clinical research studies in accordance with approved protocols.
• Oversees & coordinates conduct of daily activities of research studies.
• Ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements.
• Monitors subsite patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional.
• Participates in extracting, coding, and analyzing clinical research data.
• Assists with preparation and submission of publications, research reports, and grant proposals.

Senior Clinical Research Coordinator – Clinical Trials Office

• Lead end-to-end clinical trial execution, ensuring delivery against timelines, quality standards, and budget
• Provide operational oversight of site management and monitoring activities, including on-site and centralized monitoring
• Identify, assess, and proactively mitigate clinical and operational risks using a risk-based management approach (RACT)
• Serve as the primary escalation point for CRAs, investigative sites, and cross-functional stakeholders
• Partner closely with Study Start-Up, Data Management, Biostatistics, Safety, and Patient Recruitment teams to drive milestone achievement
• Leverage integrated systems and data (CTMS, EDC, ePRO, TMF, dashboards) to monitor performance, trends, and risk indicators
• Ensure ongoing inspection readiness and compliance with ICH-GCP, SOPs, and global regulatory requirements
• Lead study-specific training and foster alignment across the clinical trial team
• Review metrics and operational data to anticipate challenges and implement timely solutions
• Mentor and support CRAs, contributing to a culture of accountability, continuous improvement, and collaboration

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