Clinical Research

• Promote good clinical practices in the conduct of clinical investigations
• Assure compliance with protocol and regulatory requirements
• Review technical operations and ensure processes, protocols, and procedures are quality controlled
• Coordinate assigned research studies at all levels of acuity within the scope of licensure
• Plan and design forms and source-document tools for protocol implementation
• Document protocol deviations and exemptions
• Obtain, review, abstract, record, correct, and maintain source documents and case report form data
• Key and transmit electronic study data and resolve data queries
• Maintain study article dispensing logs and study-related files
• Prepare case report forms and source documents for sponsor or audit review
• Monitor enrollment goals and modify recruitment plans as needed
• Maintain screening and enrollment logs and follow patient populations clinically
• Review eligibility criteria and required medical-record documentation with investigators
• Explain protocols, informed consent forms, and follow-up procedures to potential subjects
• Conduct subject interviews and obtain informed consent before study procedures
• Follow randomization procedures and assure study-article administration
• Schedule follow-up visits and review subject diaries and questionnaires
• Ensure specimen collection, batching, and shipping
• Assess subject compliance and report laboratory values or alerts to investigators and sponsors
• Protect patient privacy and securely store or dispose of sensitive documents
• Communicate with subjects, research teams, IRBs, sponsors, CROs, primary care providers, and monitors
• Submit protocol amendments, progress reports, regulatory documents, and adverse-event notifications within required timeframes
• Schedule and participate in sponsor monitoring visits
• Clarify enrollment, sponsor-expectation, and study-procedure questions with investigators and sponsors
• Integrate proposed clinical trials with current research activities
• Attend investigator meetings and confirm required approvals and informed-consent documents before study initiation
• Educate patients on medication or device use in the study
• Provide management feedback on integrating research operations into clinic workflows

Clinical Research Coordinator II

• Identify, assess, document, escalate, and manage study risks and operational issues
• Develop and implement mitigation and corrective action strategies
• Develop and maintain project plans, schedules, projections, resource plans, and status reports
• Lead and coordinate cross-functional team activities for assigned clinical trials
• Support study development and lead operational planning, implementation, conduct, and management from initiation through completion
• Review and support development of study-related materials, including monitoring reports and clinical trial agreements
• Support budget development and related scope of work
• Participate in vendor identification, evaluation, selection, contracting, and performance oversight
• Work with Regulatory, Quality, and other staff to maintain inspection-readiness
• Coordinate study information and records supporting registration objectives
• Track study progress against timelines, milestones, budgets, accrual goals, and operational components
• Participate in SOP and study operations process/system development and implementation
• Manage multiple projects and responsibilities within time constraints
• Serve as project manager for industry collaborations and vendor management
• Liaise with medical, regulatory, quality, protocol, legal, statistical, data management, and financial personnel
• Serve as primary point of contact for industry partners
• Ensure contract deliverables are fulfilled according to milestones
• Analyze study performance metrics and operational data
• Oversee site performance, enrollment/accrual, study conduct, protocol compliance, operational issues, and timely completion of study activities
• Implement study plans and lead accrual enhancement initiatives
• Participate in and conduct visits/meetings with investigative sites, physicians, vendors, and consultants
• Build relationships with site staff and address study management issues
• Conduct site management while maintaining inspection-readiness
• Oversee monitoring CROs, including performance, reports, deliverables, timelines, quality metrics, escalation, and follow-up
• Develop and contribute to study reports, presentations, and stakeholder status updates
• Contribute to study-level quality management, KPI monitoring, quality concern escalation, CAPA implementation, study documentation, and Quality Monitoring and Management Committee activities

Clinical Study Manager

• 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 site staff training and maintain compliance records
• Monitor patient safety and ensure timely AE/SAE/PQC reporting
• Support subject recruitment and retention
• Oversee drug accountability and 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
• Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners

Clinical Research Associate II

• Advance AbbVie’s clinical development pipeline by supporting excellence in clinical research
• Serve as the primary point of contact for investigative sites
• Provide contextual information on clinical trials and connect stakeholders with investigative sites
• Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles
• Conduct site evaluation, site training, routine monitoring, and site closure monitoring
• Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
• Develop and customize site engagement strategies for assigned studies
• Gather site insights and use CRM tools to report and track progress and measure impact
• Connect study protocols, scientific principles, and trial requirements to daily trial execution
• Evaluate recruitment and retention techniques based on the patient disease journey
• Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge
• Mentor and train less experienced CRAs and contribute to their development
• Participate in global or local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team
• Detect study-performance or patient-safety issues and resolve site risk signals
• Implement preventative and corrective action plans to mitigate risk and promote compliance
• Identify, evaluate, and recommend investigators and clinical sites
• Ensure quality and timely submission of site data and safety-event reporting
• Maintain audit and regulatory inspection readiness at assigned sites
• Manage investigator payments as applicable

• Serve as the primary point of contact for investigative sites
• Provide contextual information on clinical trials and connect stakeholders with investigative sites
• Align, train, and motivate site staff and principal investigators on clinical trial goals, protocols, and patient treatment principles
• Conduct site evaluation, training, routine monitoring, and site closure activities in compliance with protocols, regulations, GCPs, ICH Guidelines, SOPs, and quality standards
• Customize site engagement strategies and gather local/site insights
• Use CRM tools to report and track progress and measure strategy impact
• Connect study protocols, scientific principles, and clinical trial requirements to daily trial execution
• Evaluate recruitment and retention techniques based on the patient disease journey
• Develop therapeutic area, asset, clinical landscape, and patient journey knowledge
• Mentor and train less experienced CRAs
• Participate in global/local task forces and initiatives
• Conduct continuous risk assessment with the Central Monitoring team
• Resolve site risk signals and implement preventative and corrective action plans
• Identify and evaluate potential investigators and sites
• Ensure quality and timely submission of site data and safety-event reporting
• Maintain audit and regulatory inspection readiness
• Manage investigator payments according to executed contracts

• 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 site staff training and compliance records
• Monitor patient safety and AE/SAE/PQC reporting
• Support subject recruitment and retention
• Oversee drug accountability and 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
• Collaborate with CTAs, LTMs, and CTMs

Clinical Research Associate – Cross Therapeutic

• Develop oncology clinical data review plans for assigned studies
• Conduct ongoing oncology clinical data review and analysis, including efficacy and safety-related data, using listings, visual analytics, tables, figures, graphs, and EDC
• Present key oncology data trends and findings to the Medical Monitor, Study Team, and Client
• Collaborate with cross-functional study team members to ensure protocol-defined variables are collected and reported accurately
• Track and analyze potential safety events with Pharmacovigilance and Medical Monitoring
• Contribute to discussions on potential study or strategy modifications based on clinical data review
• Create data summary slides for Safety Review Committee Meetings and Data Review Meetings
• Query EDC data during clinical review, follow up promptly, and identify potential protocol deviations
• Partner with vendors and study team members to ensure accurate endpoint reporting
• Serve as a point of contact for site staff and monitors for protocol and clinical inquiries
• Collaborate with Data Management on CRF design, CRF instructions, and data quality plans
• Review data-driven sections of regulatory and clinical reporting documents, including CSRs, INDs, NDAs/BLAs, annual reports, and IBs
• Provide scientific writing support for patient narratives, abstracts, posters, and presentations
• Mentor and train junior staff
• Utilize visual analytics tools to interpret and communicate data insights

Clinical Scientist

• Support clinical trial sites from study start-up through closeout
• Ensure studies comply with protocols, regulatory requirements, and company procedures
• Conduct site qualification, initiation, monitoring, and closeout visits
• Provide training and support to investigators, study coordinators, and site staff
• Monitor protocol compliance, data quality, and Good Clinical Practice (GCP) requirements
• Review source documents and verify clinical study data for accuracy and completeness
• Ensure only eligible participants are enrolled
• Manage and maintain study and regulatory documentation
• Monitor investigational product accountability and inventory
• Review adverse event reporting for accuracy and compliance
• Assess site performance, including patient recruitment and retention efforts
• Prepare monitoring reports and communicate findings, risks, and corrective actions
• Build relationships with clinical research sites and internal stakeholders
• Develop knowledge of applicable clinical research regulations and study types
• Report to the Clinical Manager and partner with Clinical Project Teams and Operations leadership

Clinical Research Associate I

• Contribute to data management activities supporting clinical studies across all stages of clinical drug development
• Lead cross-functional reviews of eCRF content and support eCRF development
• Support database build activities, including review of edit check specifications and user acceptance testing
• Monitor vendor data collection, coding, and cleaning through study metrics and targeted data reviews
• Oversee database lock activities and archive study data
• Collaborate with Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance, CROs, laboratories, and other vendors
• Establish cross-functional internal data review plans, coordinate data cuts/transfers, and conduct data reviews
• Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications, and other study documentation
• Represent data management and communicate requirements, strategy, timelines, and deliverables in internal and external meetings
• Participate in drafting and/or reviewing timelines and ensure deliverables and milestones are met
• Review clinical protocols/amendments, clinical study reports, statistical analysis plans, and related documents
• Support GCP inspection readiness
• Demonstrate alignment with company values
• Perform other duties as assigned

Clinical Data Manager

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Participate in all stages of clinical studies, including identifying potential sites
• Perform study start-up activities, collect regulatory documents, and support contract and budget negotiations
• Train sites to collect data properly and report potential safety-related events
• Manage site activities during study maintenance
• Close down research activities at sites after study completion
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed consent, safety-event reporting, and applicable regulatory requirements

Clinical Research jobs in Illinois

Clinical Research Coordinator II

Clinical Study Manager

Clinical Research Associate II

Clinical Research Associate II

Clinical Research Associate II

Clinical Research Associate – Cross Therapeutic

Clinical Scientist

Clinical Research Associate I

Clinical Data Manager

Senior Clinical Research Associate – CNS/Psychiatry