ICON plc

Research Analyst

• Meeting/greeting clinical research volunteers as they come into the clinic
• Checking their vitals (height, weight, blood pressure, BMI)
• Ensuring study participants are healthy enough to participate in the clinical trial according to the protocol of a study
• Taking vital signs and performing phlebotomy on study subjects
• Ensuring the comfort and well-being of subjects throughout the research process
• Following clients' protocols when conducting vital sign assessments and phlebotomy procedures
• Chaperoning study subjects during breaks outside, offering personalized care and ensuring comfort

Medical Research Associate – PRN

Project Manager

• Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery.
• Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration.
• Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track.
• Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives.
• Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders.

Clinical Operations

• Collaborate with cross-functional teams to design and implement effective clinical trial enrollment
• Collaborating with cross-functional teams to develop and implement comprehensive clinical trial protocols.
• Overseeing and managing the day-to-day operations of clinical trials, ensuring compliance with regulatory standards.
• Analyzing and interpreting clinical trial data, identifying trends, and providing insights to optimize study outcomes.
• Proactively addressing challenges and implementing effective solutions to ensure the successful execution of clinical trials.
• Communicating effectively with internal and external stakeholders to foster strong partnerships and facilitate smooth trial processes.

Manager, Clinical Operations II / Clinical Study Manager II

Affiliate Manager

• Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
• Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Maintaining accurate and up-to-date records of regulatory submissions and approvals.
• Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
• Participating in study start-up meetings and providing input on regulatory requirements and timelines.

Site Activation Partner

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Clinical Site Manager II

Compliance

• Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues, and clients providing advice
• Effectively manage the preparation of regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements
• Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.
• Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.
• Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
• Enthusiastically monitors for new regulatory requirements and shares key findings.
• Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.
• Experience in US FDA Drug listing (NDC) process, Drug establishment Registrations, Lot Distribution Reports
• Serve as US Agent for client submissions and act as interface with local agency and sponsor
• Support right from preclinical to post approval activities for client submissions.

Director, Regulatory Affairs – CMC

Clinical Research

• Leading the coordination and implementation of clinical trial activities, including patient recruitment, screening, enrollment, and follow-up, ensuring compliance with protocol requirements and regulatory standards.
• Overseeing the maintenance and organization of study documentation and regulatory files, managing study binders, case report forms (CRFs), and electronic data capture (EDC) systems.
• Collecting, recording, and entering data into study databases and EDC systems, performing data query resolution and ensuring data accuracy and completeness.
• Assisting with the preparation and submission of regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
• Providing guidance and training to junior staff and study team members on study procedures, protocol requirements, and regulatory compliance

Clinical Research Coordinator 2

• Assisting in the planning, initiation, and execution of clinical trial activities
• Conducting site feasibility assessments and participating in site selection processes
• Coordinating with investigative sites to ensure compliance with study protocols and regulatory requirements
• Monitoring study progress and data collection activities to ensure quality and accuracy
• Assisting in the preparation and review of study documentation and reports

In-House Clinical Research Associate

Designer

• Functions as lead for all System Designer responsibilities.
• Leads in the support and review for the re-use of library items.
• Develops materials for the bid defense process and client demonstrations.
• Organizes, creates, and oversees the administration of training and mentoring for junior levels.
• Collaborates with external professionals to troubleshoot process or implementation issues.

Senior Clinical System Designer, Sponsor Dedicated

Software Engineer

• Lead the creation and validation of advanced SAS programs that support statistical analysis, data reporting, and critical decision‑making across clinical studies.
• Partner closely with biostatisticians to translate scientific objectives into robust analysis plans and ensure the right methodologies are applied.
• Own the quality of statistical outputs, performing rigorous QC checks to ensure compliance with study requirements and international regulatory standards.
• Contribute to regulatory submissions, helping prepare statistical sections of reports, presentations, and documentation for global health authorities.
• Mentor and guide junior programmers, sharing best practices, coaching on technical development, and strengthening team capability.

Principal Statistical Programmer

• Overseeing day-to-day site management activities, ensuring that clinical trial sites comply with study protocols, regulatory requirements, and timelines.
• Collaborating with site staff and cross-functional teams to resolve issues, monitor progress, and ensure timely data collection and reporting.
• Assisting with site initiation, monitoring visits, and close-out activities to ensure the proper execution of clinical trials.
• Providing guidance and mentorship to junior site management staff, fostering collaboration and process improvement.
• Preparing and maintaining site management documentation, including site reports, communications, and updates on site performance.

ICON plc

Medical Research Associate – PRN

Project Manager

Manager, Clinical Operations II / Clinical Study Manager II

Site Activation Partner

Clinical Site Manager II

Director, Regulatory Affairs – CMC

Clinical Research Coordinator 2

Clinical Research Coordinator 2

In-House Clinical Research Associate

Senior Clinical System Designer, Sponsor Dedicated

Principal Statistical Programmer

Clinical Trial Specialist

Senior CRA / CSM

Project Manager

Senior Clinical System Designer