ICON plc

Associate

• Lead the initiation of clinical trials
• Contribute to site start-up and activation activities
• Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Manage records of regulatory submissions, approvals, and correspondence
• Provide guidance and support to study teams on regulatory requirements and study start-up best practices
• Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

Study Start Up Associate II

Research Coordinator

• Manage clinical trial operations activities, supporting teams and stakeholders to deliver high-quality outcomes across clinical programs
• Ensure meaningful and collaborative scientific exchange through engagement activities
• Manage the operations of the client’s Investigator Studies Program
• Manage Congress Operations activity for the therapeutic area
• Project manage and/or support investigator-initiated studies, scientific congresses, and Research & Development Congress support
• Contribute to the development and refinement of the Therapeutic Area Scientific and Medical Affairs Strategic Plan
• Ensure oversight of activities to impact the global scientific strategy
• Co-lead with the ISP Chair and support the ISP committee with review, decision making, and operational management of research proposals
• Provide oversight of Therapeutic Area Company ISP operations to ensure investigator research is compliantly and efficiently managed
• Support logistical and strategic planning of R&D activities at scientific congresses, including daily debriefs and scientific leader engagements
• Co-lead with the EDSA and serve as planning manager for disease-area scientific engagements
• Develop and update the scientific leadership strategy
• Travel to scientific congresses approximately 6 times per year

Scientific Leadership Research Coordinator

Clinical Research

• Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensure protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborate with investigators and site staff to facilitate smooth study conduct
• Perform data review and resolution of queries to maintain high-quality clinical data
• Contribute to the preparation and review of study documentation, including protocols and clinical study reports

Clinical Research Associate

General

• Lead the development and oversight of informed consent strategies and documents for complex, global clinical studies
• Take ownership of scientific operations deliverables, applying expertise to complex challenges
• Lead the creation, review, and optimisation of global and country-specific informed consent forms for complex or high-risk studies
• Advise study teams on informed consent strategies, including readability, cultural considerations, and local regulatory expectations
• Oversee translation, localisation, and version control processes to ensure consistency and traceability across regions
• Interact with sponsors, ethics committees, and regulatory authorities to address consent-related queries and negotiate wording
• Develop guidance, templates, and training materials to drive standardisation and best practices within the informed consent function
• Mentor junior informed consent specialists and contribute to continuous improvement initiatives

Senior Informed Consent Specialist

• Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensure protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborate with investigators and site staff to facilitate smooth study conduct
• Perform data review and resolution of queries to maintain high-quality clinical data
• Contribute to the preparation and review of study documentation, including protocols and clinical study reports
• Work in a sponsor-dedicated model supported by ICON’s global expertise

Contract Specialist

• Review and analyze contracts, agreements, and legal documents related to clinical trial activities and vendor relationships
• Negotiate contract terms and conditions with clients, vendors, and other stakeholders to ensure compliance with regulatory requirements and company policies
• Collaborate with cross-functional teams to assess contract risks, identify opportunities for improvement, and develop strategies to mitigate potential issues
• Maintain accurate and up-to-date records of contract status, milestones, and deliverables using contract management systems
• Provide guidance and support to internal teams on contract-related matters, including contract interpretation, compliance, and dispute resolution
• Take responsibility for contract management deliverables, applying skills to ensure quality and efficiency

Site Contract and Budget Specialist, Level 2

• Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensure protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborate with investigators and site staff to facilitate smooth study conduct
• Perform data review and resolution of queries to maintain high-quality clinical data
• Contribute to the preparation and review of study documentation, including protocols and clinical study reports
• Work in a sponsor-dedicated model supported by ICON’s global expertise
• Take responsibility for deliverables and work collaboratively

• Work in a sponsor-dedicated model supported by ICON’s global expertise
• Support one study in the cardiovascular/electrophysiology medical device space for A-fib
• Monitor clinical trial sites and manage site-related risks and issues
• Establish and maintain working relationships with site personnel, investigators, and internal teams
• Execute communication plans with study teams and sites
• Manage multiple priorities and produce rigorous, detailed, and precise reports
• Cover up to 65% regional travel

Senior Clinical Research Associate

• Work in a sponsor-dedicated model supported by ICON’s global expertise
• Support one study in the cardiovascular/electrophysiology medical device space focused on A-fib
• Monitor clinical trial sites and identify and mitigate risks
• Establish and maintain working relationships with site personnel, investigators, and internal teams
• Communicate effectively with study teams and sites using a well-executed communication plan
• Manage multiple priorities in a dynamic environment
• Prepare rigorous, detail-oriented, and precise reports
• Cover the Central/West region with up to 65% regional travel

• Facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements
• Deliver site start-up and activation work to a high standard
• Assist in preparing and submitting regulatory documents, including clinical trial applications and ethics committee submissions
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Maintain accurate and up-to-date records of regulatory submissions and approvals
• Support study teams in developing study documents, including protocols, informed consent forms, and investigator brochures
• Participate in study start-up meetings and provide input on regulatory requirements and timelines

Study Start Up Associate

• Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensure protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborate with investigators and site staff to facilitate smooth study conduct
• Perform data review and resolution of queries to maintain high-quality clinical data
• Contribute to preparation and review of study documentation, including protocols and clinical study reports
• Take responsibility for clinical trial monitoring deliverables and work collaboratively

Clinical Data Coordinator

• Perform routine reviews of clinical and third-party data for subjects enrolled in clinical research protocols based on edit check/output specification documentation
• Maintain clinical data management-related study documentation as appropriate
• Perform local lab data entry and local lab data review activities as required
• Execute data review and analytic requirements on low- to medium-complexity work
• Manage the third-party data reconciliation process
• Assist the Clinical Data Science Lead in developing eCRFs, Data Validation Specifications, and Study Specific Procedures

QA Engineer

• Ensure the quality and compliance of clinical trials, interpret regulatory requirements, and contribute to the advancement of innovative treatments and therapies.
• Develop and implement quality assurance strategies and processes to support clinical trial activities.
• Conduct quality assessments and audits to ensure compliance with regulatory standards and guidelines.
• Collaborate with project teams to identify and address quality issues and implement corrective actions as needed.
• Provide guidance and support to staff regarding quality assurance policies, procedures, and best practices.
• Contribute to the development and maintenance of quality management systems and documentation.
• Coordinate quality assurance and compliance delivery, resolve issues, and develop team capability.

Study Start Up Associate II

Scientific Leadership Research Coordinator

Clinical Research Associate

Senior Informed Consent Specialist

Clinical Research Associate

Site Contract and Budget Specialist, Level 2

Clinical Research Associate

Senior Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Senior Clinical Research Associate

Study Start Up Associate

Clinical Research Associate

Clinical Data Coordinator

Quality Assurance Manager