ICON plc

Clinical Research

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders to facilitate smooth trial operations

Senior Clinical Research Associate

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and GCP standards
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams on timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders
• Monitor respiratory and cardiovascular studies in the Greater Toronto Area

Clinical Research Associate

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice standards
• Conduct site visits to assess site performance, resolve issues, and provide support
• Collaborate with cross-functional teams on timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders
• Monitor respiratory and cardiovascular studies in the GTA area

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders to facilitate smooth trial operations
• Monitor respiratory and cardiovascular studies in the Greater Toronto Area

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks requiring technical depth, focusing on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams on timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and GCP standards
• Conduct site visits to assess site performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams on timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders
• Support Phase I Oncology trials in a sponsor-dedicated model

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH Good Clinical Practice (GCP) guidelines.
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites.
• Performs site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations.
• Reviews and verifies accuracy of clinical trial data collected onsite or remotely.
• Provides regular site status information to team members and trial management and updates trial management tools.
• Completes monitoring activity documents as required by sponsor SOPs.
• Works with clinical team members to resolve trial and clinical issues.
• Escalates site and trial-related issues until resolved or closed.
• Performs essential document site file reconciliation, source document verification, and query resolution.
• Assesses investigational product accountability, dispensation, and compliance.
• Verifies serious adverse event reporting according to trial specifications and ICH GCP guidelines.
• Communicates with investigative sites and updates applicable tracking systems.
• Ensures required training is completed and documented.
• Functions with little oversight at the senior level and may serve as a subject matter expert.
• May be assigned complex studies and/or sites.
• Provides leadership to assigned clinical operations projects.
• Serves as observation and performance visit leader.
• Interacts with other functional areas to resolve site issues and facilitate trial timelines.

• Oversee and manage clinical trial activities according to protocol, regulatory requirements, and industry standards
• Lead clinical trial monitoring tasks with a focus on quality and continuous improvement
• Monitor clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
• Conduct site visits to assess performance, resolve issues, and support successful trial execution
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
• Provide training and guidance to site staff and other CRAs
• Build and maintain relationships with site personnel and stakeholders
• Monitor cardiovascular and respiratory studies in Quebec

• Manage day-to-day clinical trial management activities, supporting the team to deliver quality outcomes
• Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards
• Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures
• Build and manage relationships with trial investigators and stakeholders
• Ensure trials comply with local, national, and international regulations and ethical guidelines
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management
• Support the development of the team and manage competing priorities

Lead Clinical Research Associate

Data Scientist

• Manage day-to-day clinical data science activities, supporting the team to deliver quality outcomes
• Lead the design and implementation of data science strategies to enhance clinical trial data analysis
• Collaborate with cross-functional teams to identify key data requirements and analytical needs
• Oversee the development of statistical models and analytical tools to optimize data interpretation
• Mentor and guide team members in best practices for data analysis and visualization
• Communicate findings and insights to stakeholders through presentations and reports, influencing project direction

Clinical Data Science Lead

• Perform site management activities to support the client's Oncology site success and maintain continuous inspection readiness
• Act as primary contact and facilitate communications between the client's clinical trial team and sites
• Perform remote and on-site monitoring/co-monitoring visits, including Site Qualification, Site Initiation, Interim Monitoring, and Close-Out Visits
• Perform oversight activities to assess monitoring quality and train or mentor less experienced CRAs
• Document monitoring activities and submit or approve visit reports
• Manage site essential document collection and TMF reconciliation with site files
• Support sites with local IRB/EC submissions and confirm approvals
• Review site KRI metrics, issues, and action items to detect trends and ensure resolution
• Determine root causes and develop or implement site CAPA plans
• Deliver training on protocols, SOPs, GCPs, and regulations
• Support sites and the client’s regulatory inspections
• Contribute to site identification, feasibility, qualification, and activation activities
• Lead site engagement initiatives and foster relationships with Oncology sites and networks

Project Manager

• Coordinate project and programme management delivery
• Resolve issues and develop team capability
• Act as the Sponsor's main contact person regarding ICON services, including day-to-day study management
• Attend and represent ICON at Sponsor meetings
• Manage 10–15 studies in accordance with Good Clinical Practice
• Communicate study progress to Sponsors in a responsible and professional manner
• Provide Sponsors with regular management reports
• Provide ICOLAB support to sponsor personnel
• Design and analyze clinical trials, interpret complex medical data, and contribute to innovative treatments and therapies

Project Manager, Laboratory

• Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
• Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
• Perform remote and on-site monitoring/co-monitoring visits, including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits, to ensure data integrity and subject safety
• Perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
• Document monitoring activities and submit/approve visit reports
• Manage site essential document collection and TMF reconciliation with site files
• Support sites with local IRB/EC submissions and confirm approvals
• Review site KRI metrics, issues and action items to detect trends and ensure prompt resolution
• Determine root causes and develop/implement site CAPA plans
• Deliver training to ensure sites comply with protocols, SOPs, GCPs and regulations
• Support sites and the client's regulatory inspections
• Contribute to site identification, drive site feasibility and qualification progress, and support site activation activities
• Lead site engagement initiatives and foster relationships with key Oncology sites and networks

• Coordinate project and programme management delivery
• Resolve issues and develop team capability
• Act as the Sponsor's main contact person regarding ICON services, including day-to-day management of studies
• Attend and represent ICON at Sponsor meetings
• Manage 10-15 studies in accordance with Good Clinical Practice
• Communicate study progress to Sponsors and provide regular management reports
• Provide ICOLAB support to sponsor personnel

• Oversee the planning, execution, and successful completion of clinical trials.
• Ensure adherence to timelines, budgets, and regulatory guidelines.
• Coordinate clinical trial management delivery, resolve issues, and develop team capability.
• Oversee the clinical portion of the budget and ensure efficient resource allocation.
• Develop monitoring plans and tools to ensure effective study oversight.
• Train and mentor Clinical Research Associates (CRAs) to optimize performance.
• Drive enrollment and lead study start-up activities while adhering to timelines.
• Review trip reports and implement corrective and preventative action plans when necessary.
• Foster productive relationships with Sponsors, vendors, and cross-functional teams.
• Collaborate with cross-functional teams, manage site relationships, and provide strategic guidance.

Senior Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Senior Clinical Research Associate

Senior Clinical Research Associate

Senior Clinical Research Associate

Senior Clinical Research Associate

Clinical Research Associate

Lead Clinical Research Associate

Clinical Data Science Lead

Senior Clinical Research Associate

Project Manager, Laboratory

Senior Clinical Research Associate

Project Manager, Laboratory

Senior Clinical Trial Manager