Clinical Study Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Associate to join our diverse and dynamic team. Working as a Clinical Study Associate exclusively assigned to a Pharmaceutical Company, you will perform tasks related to planning and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. You will provide support for critical day to day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with CTA Managers. You will collaborate with Clinical Operations Study Managers, study teams, and CROs to support clinical study activities, as defined by the clinical trial operating model. What you will be doing - Review study documentation. - Support Risk-Based monitoring. - Attend key team meetings. - Support inspection readiness and clinical trial systems. - Support vendor contract administration. - Support study close-out activities. Your profile - Bachelor's or advanced degree in Life Sciences, Health Sciences, or a related field. - 1-2 years experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry. - Strong organizational and time management skills, with the ability to prioritize tasks and manage competing priorities effectively. - Strong attention to detail and problem-solving abilities, with a commitment to ensuring data accuracy, integrity, and compliance. - Excellent communication and interpersonal skills, with the ability to collaborate cross-functionally and build strong relationships. - Strong regulatory knowledge. - Fluent English. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Experienced CRA I - Sponsor Dedicated | Oncology / Neurology | 6 months of monitoring experience required (Home-Based - Maimi, FL) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes Conducts Source Document Review of appropriate site source documents and medical records Verifies required clinical data entered in the case report form (CRF) is accurate and complete Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture Verifies site compliance with electronic data capture requirements - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets. - May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out Knowledge of local requirements for real world late phase study designs Chart Abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff Qualifications: - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - 6 months of independent monitoring experience required - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 30% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $62,000.00 - $108,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Sr Medical Scientist - China studies experience & Chinese language as a plus - Argentina, Brazil, Mexico, Canada or US Home Based Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans. - Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews. Pro-actively identifies and resolves medical data review issues as they arise. - Authors medical data queries and reviews query responses, approves query closure in association with Medical Director. - May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed. - Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed. - Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review. - Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner. - Attends and present at Trusted Process meetings and may participate in internal and external audits. - Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology. - Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans. - May manage limited number of direct reports. May participate or conduct interviews Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversees site interactions post activation through site closeout • This may include patient recruitment, investigator payments or other related activities • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT) • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations • Participates and presents in key meetings such as Kick Off Meeting • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members • This may include accompanying CRA team members to sites for observation or conflict resolution • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines • Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed • Ensures access and audit trail reviews are conducted as required • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan • Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity • Document requested revisions and approvals in CTMS • Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements • Provides solutions for obstacles in protocol execution and site management • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations • This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA) • Supports Inspection Readiness for clinical trial management scope • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks • Develop and support execution of corrective action plans at site and study level • Supports and completes activities to achieve data cut and lock deadlines • Provides feedback to line managers on staff performance including strengths as well as areas for development • May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects • May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation