Clinical Research

• Independently manage and monitor site activities for assigned clinical studies
• Conduct site qualification, site initiation, interim monitoring, and close-out visits
• Perform site evaluation visits and assess investigator-site capability
• Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
• Maintain audit-ready Investigator Site Files and ensure timely document upload to the Trial Master File
• Communicate directly with investigational sites regarding visit planning, query resolution, action items, and site management
• Document clinical-trial-material accountability, stability, and storage conditions
• Perform investigational product inventory and coordinate return or destruction of unused materials
• Serve as primary site contact and coordinate correspondence and timely clinical-data transmission
• Perform study close-out visits, investigational-product reconciliation, site-file reconciliation, query resolution through database lock, and outstanding-action resolution
• Complete internal and study-related training within required timelines
• Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports
• Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable
• Follow safety practices while traveling and visiting clinical research sites

Senior Clinical Research Associate – CRO Contract

• Independently manage and monitor site activities for assigned clinical studies
• Conduct site qualification, site initiation, interim monitoring, and close-out visits
• Ensure compliance with protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines
• Perform site evaluation visits and assess investigators’ site capabilities
• Conduct study initiation activities, review protocols and regulatory issues, and train site personnel
• Ensure Investigator Site Files remain audit-ready and documents are uploaded to the Trial Master File
• Communicate with investigational sites regarding visit planning, query resolution, action items, and site management
• Document clinical trial material accountability, stability, and storage conditions; perform investigational product inventory
• Coordinate site correspondence and ensure timely transmission of clinical data
• Perform close-out visits, investigational product reconciliation and disposition, study file reconciliation, query resolution through database lock, and outstanding action-item resolution
• Complete internal and study-related training within required timelines
• Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports
• Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable

Senior Clinical Research Associate – CRO-Contract

• 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

• Design clinical trials, provide oversight, and support site and subject retention
• Ensure completion of clinical trial protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, and related documents
• Participate on study teams and cross-functional teams as delegated by the Vice President, Clinical Development
• Ensure consistent use of language and criteria across multiple endocrine projects
• Ensure study integrity and track accumulating safety and efficacy data
• Anticipate clinical trial obstacles and implement solutions
• Analyze, evaluate, and support accurate interpretation and reporting of clinical data
• Draft and review clinical documents, manuscripts, presentations, and regulatory submissions
• Maintain current knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
• Collaborate with cross-functional colleagues as a clinical research resource to optimize product development
• Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders
• Support corporate strategic and organizational initiatives
• Assist with commercial activities as needed
• Complete assigned tasks thoroughly, accurately, and on time
• Adhere to rigorous ethical standards
• Travel up to 20% domestically and internationally for scientific meetings

Clinical Scientist

• Accountable for regional study delivery with inspection readiness quality, within agreed timelines and budget
• Act as regional lead for multiple studies across an indication or program
• Lead regional clinical operations teams and external regional partners
• Serve as escalation point for regional study issues
• Align regional deliverables with overall study goals
• Develop regional tools, work instructions and SOPs
• Lead regional planning and management of clinical studies from feasibility through closeout
• Manage study start-up and recruitment timelines and track progress
• Drive trial feasibility, country allocation and site selection
• Coordinate local adaptations of global study documents and regulatory/ethics submissions
• Maintain regional and country information in study systems
• Collaborate with CRAs to ensure study execution and review monitoring reports
• Ensure regional and country-level Trial Master File creation, maintenance and quality control
• Provide input on clinical supplies, drug inventories, labels and comparator drug status
• Manage regional data collection, data entry and query resolution
• Support Clinical Study Report planning and execution
• Monitor compliance with protocol, SOPs, ICH/GCP and applicable regulations
• Ensure inspection readiness and prepare sites for audits and inspections
• Lead quality improvements and share best practices
• Select and manage regional vendors
• Manage regional study budgets
• Address investigator fees, site payments and patient travel reimbursement
• Manage regional resource needs and utilization
• Provide performance feedback and mentor junior team members

Regional Clinical Study Manager

• Accountable for regional study delivery with inspection-ready quality, agreed timelines and budget
• Lead the regional clinical operations team and oversee external regional partners
• Act as escalation point for regional study issues
• Align regional deliverables with overall study goals
• Lead regional operations meetings and represent the regional study team at internal and cross-functional meetings
• Plan and manage assigned clinical studies from feasibility through regional closeout
• Generate, manage and maintain regional study start-up and recruitment timelines
• Drive trial feasibility, country allocation and site selection with relevant stakeholders
• Provide regional input on global study plans
• Coordinate local adaptations of global study documents and support timely regulatory and EC/IRB submissions
• Ensure study submissions in assigned countries in collaboration with study start-up and regulatory teams
• Maintain regional and country information in study systems and tools
• Collaborate with CRAs on site execution and review/sign off monitoring reports
• Ensure country and site-level Trial Master Files are created, maintained and quality-checked
• Provide input on regional drug inventories, local drug labels, comparator drug approvals and reimbursement status
• Manage regional trial data collection, data entry and query resolution
• Support Clinical Study Report planning and execution
• Handle escalated site issues and monitor compliance with protocols, SOPs, ICH/GCP and regulations
• Ensure regional inspection readiness and implement solutions to study issues
• Prepare sites for audits and inspections and drive responses to findings
• Share learnings and best practices across teams
• Lead improvements and contribute to work instructions and SOPs
• Select and manage regional study vendors with sourcing
• Manage regional study budgets
• Coordinate investigator fees, site payments and patient travel reimbursement
• Identify regional resource needs and contingency plans
• Monitor regional resource utilization
• Provide performance feedback and mentor junior team members as needed

• Assist the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies
• Support adjudication, medical monitoring, imaging data reconciliation, preparation of meeting materials, and protocol deviation management
• Support a single study or multiple studies
• Lead a study with limited scope, such as Survival Follow-up
• Interact with internal and external stakeholders, including study sites and committees, in support of clinical study objectives
• Complete required training curriculum
• Complete timesheets accurately and on time
• Submit expense reports as required
• Update CV as required
• Maintain working knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements

Clinical Scientist – FSP

• Contribute to the scientific development of clinical development programs and individual studies within the Hematology therapeutic area
• Provide scientific and clinical development input for the safe, efficient, timely, high-quality and compliant execution of assigned programs
• Author and contribute to program- and study-level documents and training materials, including clinical development plans, investigator brochures, protocols, eCRFs, ICFs, study reference manuals and investigator trainings
• Contribute to medical monitoring oversight strategies and implement them to ensure patient safety oversight and data integrity, including ongoing blinded-data review
• May lead development of a Clinical Development Program
• Contribute to authorship and review of manuscripts, conference abstracts and related materials
• Collaborate with internal and external cross-functional stakeholders to translate clinical development strategy and protocols into operational deliverables
• Contribute to scientific analysis and interpretation of clinical data
• Write clinical study reports, scientific meeting presentations, peer-reviewed publications and regulatory submission documents
• Manage processes and liaisons supporting external study oversight committees, including steering, independent data monitoring and adjudication committees

Principal Clinical Scientist, Clinical Development – Hematology

• Develop deep understanding of clinical data needs, including medical records, lab results, and ADT, and data usability requirements across Devoted Health Plans and Devoted Medical
• Collaborate and align on outcomes with external partners and internal teams including Network Management, Risk Adjustment, Stars, Devoted Medical, Payment Integrity, and others
• Analyze clinical data availability across geographical areas to identify data gaps, causes, and opportunities to obtain data
• Define an execution plan to ensure broad clinical data coverage in markets and usability by stakeholder teams
• Implement technical integrations with Health Information Exchanges, Labs, Electronic Health Record systems, data aggregators, and other clinical data sources
• Ensure quality of received clinical data
• Explore new frameworks, optimize connections, and evaluate vendor relationships to scale data exchange, improve data quality, and minimize data gaps
• Apply new processes and methodologies using AI to ensure clinical data is consistently available and usable
• Define, implement, and drive KPIs to measure success

Manager, Clinical Data Acquisition

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct site selection, initiation, routine monitoring, and close-out visits
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain documentation in CTMS and eTMF systems
• Support and track site staff training and compliance records
• Monitor patient safety and ensure timely AE/SAE/PQC reporting
• Support subject recruitment and retention efforts
• Oversee drug accountability and proper storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues
• Assist with site budgets and payments as applicable
• Collaborate with CTAs, LTMs, and CTMs

Clinical Research jobs in United States

Senior Clinical Research Associate – CRO Contract

Senior Clinical Research Associate – CRO-Contract

Clinical Research Data Specialist I, Clinical Trials

Clinical Scientist

Regional Clinical Study Manager

Regional Clinical Study Manager

Clinical Scientist – FSP

Principal Clinical Scientist, Clinical Development – Hematology

Manager, Clinical Data Acquisition

Clinical Research Associate II