• Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale. • In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices. • In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. • Represents the corporation by maintaining collaborative relationships with stakeholders.

The Oncology Claims Specialist 2 will coordinate coding audits and educational functions for FMOLHS and the Oncology Service Line. This individual will be responsible for drug authorizations, managing and working the edit and denial coding work queues for inpatient, outpatient clinic, and hospital-based infusion departments and will provide coding and reimbursement feedback for education opportunities identified to the Service Line and FMOLHS.

CRA II- Remote 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 Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing - Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. - Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. - Collaborating with investigators and site staff to facilitate smooth study conduct. - Performing data review and resolution of queries to maintain high-quality clinical data. - Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile - Bachelor's degree in a scientific or healthcare-related field. - Minimum of 2 years of experience as a Clinical Research Associate. - In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. - Strong organizational and communication skills, with attention to detail. - Ability to work independently and collaboratively in a fast-paced environment. - Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license Nous recherchons actuellement un(e) Attaché(e) de Recherche Clinique II pour rejoindre notre équipe diversifiée et dynamique. En tant qu’Attaché(e) de Recherche Clinique II chez ICON, vous jouerez un rôle clé dans la conception et l’analyse des essais cliniques, l’interprétation de données médicales complexes, et contribuerez à l’avancement de traitements et thérapies innovants. Vos missions - Réaliser les visites de qualification, d’initiation, de suivi et de clôture des sites d’essais cliniques. - Assurer le respect du protocole, l’intégrité des données et la sécurité des patients tout au long de l’étude. - Collaborer avec les investigateurs et les équipes des sites afin de garantir le bon déroulement des études. - Effectuer la revue des données et la résolution des requêtes afin de maintenir un haut niveau de qualité des données cliniques. - Contribuer à la préparation et à la révision de la documentation des études, notamment les protocoles et les rapports d’étude clinique. Votre profil - Diplôme de niveau licence (ou équivalent) dans un domaine scientifique ou lié à la santé. - Minimum de 2 ans d’expérience en tant qu’Attaché(e) de Recherche Clinique. - Connaissance approfondie des processus des essais cliniques, des réglementations et des lignes directrices ICH-GCP. - Excellentes compétences organisationnelles et de communication, avec un grand souci du détail. - Capacité à travailler de manière autonome et en équipe dans un environnement dynamique et rapide. - Disponibilité pour des déplacements fréquents (au moins 60 %, nationaux et internationaux – avion et voiture) et possession d’un permis de conduire valide. 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

Sr CRA - Sponsor dedicated - Brazil 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 - Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (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 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. - Per 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 via review of site source documents and medical records. 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 study 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. - Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. 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, and may, with supervision, lead, 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. - May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. - May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. 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 As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff Identify and communicate out of scope activities to Lead CRA/Project Manager Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Identify operational efficiencies and process improvements Develop country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings 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 - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected. - Ability to manage required travel of up to 75% on a regular basis 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.