Clinical Research

• Coordinate and facilitate clinical trial data for participants enrolled in clinical research studies conducted by principal investigators at University Hospitals Case Medical Center
• Assist with and complete case report form entry, review, and abstraction for clinical research involving the IRB, pharmaceutical sponsors, and internal/external agencies or committees
• Perform timely, professional data entry of clinical trial data across studies in different therapeutic areas and phases
• Identify data errors and inconsistencies according to study submission and completion guidelines
• Maintain the integrity and quality of clinical research trials
• Ensure trials are conducted in accordance with SOPs, GCP guidelines, sponsor guidelines, and current regulations
• Perform other duties as assigned
• Comply with organizational policies and standards
• Safely and securely maintain Protected Health Information (PHI)

Clinical Research Data Specialist I, Clinical Trials

• Provide a high standard of care for participants in oncology clinical trials and respond to emergency situations based on clinical research standards
• Conduct routine monitoring and close-out of clinical sites
• Maintain study files and conduct pre-study and initiation visits
• Liaise with vendors and perform other assigned duties
• Manage study sites according to project plans
• Ensure study staff receive proper materials and instructions
• Verify informed consent procedures and protocol requirements comply with applicable regulations
• Ensure the integrity of submitted Case Report Forms and other data collection tools through source-document review
• Monitor data for missing or implausible information
• Manage registries and undertake feasibility work when requested
• Complete Serious Adverse Event reporting, reports, narratives, and follow-up
• Perform CRF review, generate and resolve queries using Fortrea or client data management systems
• Assist with training new employees through activities such as co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact
• Travel frequently to client and site locations, including occasional domestic and international travel

Senior Clinical Research Associate II - Oncology

• Coordinate and manage assigned oncology clinical trials from study start-up through closeout
• Screen, recruit, and refer eligible research participants
• Coordinate participant visits, assessments, treatments, laboratory testing, and follow-up activities
• Serve as liaison among investigators, participants, sponsors, CROs, and internal clinical departments
• Collect, review, verify, and enter clinical research data into EDC systems
• Maintain regulatory binders, investigator site files, and essential study records
• Prepare and submit regulatory documents, protocol amendments, continuing reviews, adverse event reports, and IRB correspondence
• Monitor participant compliance and report protocol deviations
• Track and resolve data queries, discrepancies, and missing information
• Assist with adverse event and safety-related finding reports
• Educate participants and clinical staff on study requirements and procedures
• Protect participant confidentiality and health information under HIPAA
• Collaborate with multidisciplinary healthcare teams to support protocol adherence and participant care
• Support feasibility assessments, site activation, and enrollment initiatives
• Prepare study updates, enrollment reports, and performance metrics
• Participate in quality assurance activities, audits, inspections, and process improvement
• Maintain knowledge of oncology research practices, regulatory requirements, GCP standards, and clinical trial methodologies
• Promote participant safety, ethical research conduct, and patient advocacy
• Perform other research-related duties as assigned

Clinical Research Associate – Oncology

• Gain in-depth knowledge of OrganOx FDA-approved and investigational/research products and associated clinical procedures
• Serve as the subject matter expert on devices and procedures during IDE studies and research projects
• Support training of OrganOx employees and customers on approved, IDE, and research products and studies
• Support development of training and support materials for devices, procedures, and clinical protocols
• Train investigational/research centers, Clinical Specialists, and OrganOx personnel
• Attend cases with investigational/research devices as a technical and clinical resource
• Interface with Development and Engineering on technical questions
• Provide clinical and technical feedback to Development and Engineering
• Support investigational/research centers and OrganOx personnel regarding devices and clinical study protocols
• Support development of clinical study protocols
• Support thorough data collection and protocol-compliant data analysis
• Develop materials for clinical protocols, study procedures, data collection, and review
• Assist with development and implementation of study-specific clinical databases
• Assist Clinical Research Associates with study data review
• Support writing and review of clinical study reports and clinical portions of FDA submissions
• Identify and report protocol challenges and compliance issues to clinical management
• Maintain and develop professional relationships with investigators and research sites
• Support clinical management with departmental quality improvement decisions
• Perform other duties assigned by the VP, Clinical Affairs & Training

Clinical Research Engineer

• Provide leadership for the UH Seidman Cancer Center Clinical Trials Unit clinical research program in collaboration with the SCC CTU director
• Oversee research operations, resource allocation, and adherence to protocol requirements
• Assist the Director, Clinical Trials with departmental activities to maximize efficiency of management control systems, programs, policies, work methods, and procedures
• Manage clinical trial processes and ensure trials are generated, documented, and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines, and applicable regulations
• Oversee and implement program-wide projects
• Provide training for clinical team members
• Perform other duties as assigned
• Comply with organizational policies and standards
• Maintain patient Protected Health Information (PHI) safely and securely

Clinical Research Program Manager

• Serve as the primary site-level contact for internal and external clinical-trial stakeholders
• Conduct site qualification, initiation, routine monitoring, and close-out visits across all trial phases
• Ensure adherence to protocols, BMS SOPs, ICH GCP, and applicable regulations
• Verify clinical-trial data in electronic systems and paper records for accessibility, completeness, and accuracy
• Monitor site compliance, provide training and support, and participate in audits and inspections
• Build relationships with cross-functional teams, vendors, clinical sites, and key stakeholders
• Motivate and influence sites to meet enrollment and retention objectives
• Prepare timely, accurate, concise, professional monitoring and administrative reports
• Assess Investigators and sites for resources and capabilities and identify potential new sites
• Apply targeted, centralized, remote, and risk-based monitoring approaches
• Identify and prioritize site and study risks and support mitigation strategies
• Analyze site data and operational metrics and adjust monitoring strategies based on trends and performance
• Perform Unblinded Site Monitor activities when applicable to protect study blinding
• Review, reconcile, and oversee study drug/IMP and support label translation needs when applicable
• Support regulatory compliance audits, inspections, and corrective and preventive actions
• Support study start-up, submissions, ICF reviews, and site document collection when applicable
• Support access to BMS and vendor systems and maintain internal systems for monitoring activities
• Coordinate site activities related to database locks
• Perform timely site closure activities after required visits and follow-up are completed