Clinical Research Associate II, China 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 As a CRA II at ICON, you will design and analyze clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include: - 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: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - Bachelor's degree in a scientific or healthcare-related field. - Minimum of 1.5 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. 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

Place in the Organization At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments. The main mission of the Clinical Research Associate (CRA) is to act as uniQure’s clinical sites facing ambassador, building impactful relationships with the sites participating in our clinical programs. The CRA will be supporting the clinical sites in the proper execution of one or more protocols delivery, removing executional barriers, guiding and training the sites as well as ensuring compliance with the protocol and regulations. Key result areas (major duties, accountabilities and responsibilities) - Supports oversight of all clinical sites facing activities, from feasibility up to site closure - Perform remote or on-site monitoring visits to ensure compliance with the protocol, ICH/ GCP, validity and accuracy of data collected - Perform co-monitoring visits with CROs CRAs, as well as be the main point to review CROs CRAs monitoring visit reports and follow-up letters - Review and analyze sites’ performance including protocol deviations and recommend corrective and preventative actions - Support and direct sites with data entry and queries resolution to ensure proper data flow and ability to identify safety events - Support sites with patient’s enrollment tactics and guide them through the eligibility determination process - Provide ongoing training to sites staff around the study protocol and amendments as well as relevant study level manuals - Ensure proper ongoing filing in the investigator site file by the site staff - Ensure proper supply of IMP, labs kits and other study related supplies and equipment. - Support sites level start up activities to facilitate IRBs/ ECs submissions and approvals as well as site contracts. All within the shortest timelines possible. - Assist in the development of study plans/documents and tools, such as recruitment and monitoring plans, Informed Consent Form (ICF) templates, site binder contents, etc - Support audit/inspection readiness activities, including mock audits, support on-site audits, storyboard generation, documentation of corrective action plans - May be asked to assist or perform CTM activities, such as vendors oversight, planning and oversight of the project timelines, budget, and quality including the facilitation of internal and external meetings Qualifications & Skills - Bachelor’s degree life sciences required; science/medical related degree preferred - Minimum of 5 years of related clinical monitoring research experience with at least 3 years of on-site monitoring experience - Inspection readiness experience, required - Demonstrates excellent understanding and application of ICH/GCP guidelines, including knowing which guidelines apply to the current study phase and work, understands the implications of not following GCP/ICH guidelines, and is adept at recognizing a breach. Also demonstrates awareness and understanding of interdependencies of other GxP regulations - Experience in complex clinical research projects and early drug development very desirable, particularly within an orphan/rare disease therapeutic area - Demonstrated communication, and organizational skills, along with problem solving and conflict resolution - Strong interpersonal and communication skills, able to conduct self in diplomatic manner in challenging situations - Ability to travel up to 40% - Enthusiastic and proactive, with a can-do attitude, thrives working in a fast-paced environment and able to manage competing tasks and demands with a sense of urgency Salary Range: $100,000 - $130,000 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description Summary Sr CRA in Italy Job Description ROLE The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. KEY RESPONSABILITIES - Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. - Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. - Ensures appropriate and timely investigator site visits. - Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. - Assists in development of study-specific Monitoring Plans and training presentations as required. - Assists in set up/collection of site specific ethics documents and site contract negotiation as required. - Provides monthly billing information to finance team as required. - For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. - Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. - Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. - Ensures integrity of CRF data through meticulous and thorough source document review and verification. - Performs quality control and verification of documents collected at sites for eTMF/TMF. - Conducts investigational product accountability. - Reviews site regulatory binder for required documents. - Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. - Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. - Participates in internal, client/sponsor, scientific, and other meetings as required. - Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. - Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data. - Proactively identifies site issues and develops problem-solving strategies for sites. - Conducts audit preparation at study sites as needed. - Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. - Participates in internal, client/sponsor, scientific, and other meetings as required. - Assists in CRA new hire training and onboarding. - Performs CRA mentoring. - Collaborates with development and maintenance of Clinical Trial Management System (CTMS). - Manages and resolves conflicting priorities to deliver on commitments. - Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE - US: BS/BA from an undergraduate program (life sciences or related discipline preferred) - US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 year of clinical monitoring experience with 1 year of management experience - EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS - Quality focused; Proven ability to be careful, thorough, and detail-oriented - Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment - Able to manage priorities, organize time and solve problems - Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills - Ability to travel - Ability to manage stress - Professional, trustworthy and disciplined - Ability to problem-solve unstructured or ambiguous challenges - US: Strong command of English, both written and verbal - EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed - Excellent communication and interpersonal skills with customer service orientation - Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture - Self-starter who thrives in a collaborative, yet less structured team environment - Knowledge of clinical research, ICH GCP and local regulations - Knowledge of Regulatory and Ethical requirements - Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members - US: Permanent authorization to work in the U.S. - EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011. - EU: Graduation in a scientific health field. - EU: Adequate English Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy Contract Type Regular

Clinical Research Associate II 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 As a CRA II at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include: - 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: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - 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. - Willingness to travel as required (approximately 60%) 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