Clinical Research Associate - Oncology - Chicago 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 What You Will Be Doing: - Serve as the primary point of contact between investigational sites and the sponsor - Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out - Ensure site compliance with ICH-GCP, SOPs, and regulations - Maintain up-to-date documentation in CTMS and eTMF systems - Support and track site staff training and maintain compliance records - Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting - Support subject recruitment and retention efforts at the site level - Oversee drug accountability and ensure proper storage, return, or destruction - Resolve data queries and drive timely, high-quality data entry - Document site progress and escalate risks or issues to the clinical team - Assist in tracking site budgets and ensuring timely site payments (as applicable) - Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: - A graduate with a Bachelor’s degree in Life Sciences or equivalent preferred, or a qualified RN - Eligible to work in United States without visa sponsorship - A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry - Experience monitoring Oncology clinical trials required, preferably heme/onc - Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF - A clear communicator, problem-solver, and collaborative team player - Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Chicago near major HUB airports to support efficient regional travel 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. Salary Range $91,336.00-$114,170.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Centrally located in US ideal-near a major airport- travel throughout US The Sr CRA role is responsible for supporting monitoring and site management activities for the client Sponsored studies. Site monitoring and site management activities are conducted according to ICH GCP, applicable country/local regulations and client SOPs. Site interactions are conducted both on-site and off-site with documented interactions recorded in CTMS. The role involves collaboration with cross-functional clinical study teams and investigator site personnel to ensure study deliverables are met efficiently and effectively. The SrCRA is also responsible for the oversight of activities carried out at investigator sites where the monitoring may be supported by a CRO partner through the review of operational data and metrics. KEY RESPONSIBILITIES: Site Management and Monitoring Activities: - Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs. - Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely. - Partner with Clinical Trial Liaison (CTL) and other client functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables. - Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct. - Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements Oversight Monitoring: - Prepare and maintain Oversight Monitoring Plan - Perform review of study metrics, assess CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits - Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA - Review site source documentation and verify accurate data capture (ALCOA principles) - Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items Documentation and Reporting: - Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting. - Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner. - Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents). Issue Management and Escalation: - Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary. - Track, trend, and report issues, escalating them to the appropriate teams when required. Collaboration and Communication: - Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs. - Actively participate in team meetings and process improvement initiatives to enhance study outcomes. Inspection Readiness - Actively participate in team meetings and process improvement initiatives to enhance study outcomes. JOB REQUIREMENTS: Bachelor's degree (or equivalent) Experience: - Minimum of 5 years of related experience for Snr CRA - Strong analytical problem-solving skills and critical thinking abilities. - Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA). Skills: - Effective communication and interpersonal skills to build relationships internally and externally. - Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories. - Demonstrated ability to deliver clear and concise written reports. - Effective prioritisation and time management skills #LI-LG4 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Purpose: The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. Key Accountabilities: Oversight of Monitoring Responsibilities and Study Conduct - Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality - Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met - During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery - Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites - Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks - Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and - recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level - Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies - Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution - Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics - Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues - Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines - Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities - Support database release as needed - May undertake the responsibilities of an unblinded monitor where appropriate Clinical/Scientific and Site Monitoring Risk - Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team - Interact with investigator site heath care professionals in a manner which enhances sponsor’s credibility, scientific leadership and in order to facilitate sponsor’s clinical development goals - Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators - Drive Quality Event (QE) remediation, when applicable - Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable Collaboration - Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) - Partners with SCP and Country Study Operations Manager (SOM) - When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) - May act as a Mentor for Clinical Research Associates Skills: - Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization - Preferred therapeutic experience in Oncology - Global clinical trial experience preferred - Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations - Must be fluent in English and in the native language(s) of the country they will work in - Travel (60-80%) within area is required - Valid driver’s license and passport required Knowledge and Experience: - Demonstrated knowledge of clinical research and development processes and ability to gain command of process details - Demonstrated knowledge of global and local regulatory requirements - Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) - Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) - Demonstrated ability to support sponsor regulatory interactions/inspections - Demonstrated knowledge of the processes around protocol design and feasibility assessment - Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery - Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial - Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation - Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization Education: - Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required #LI-CF1

Our Mission All of us, for each of you, every time. Our Vision Together, serving as the trusted regional healthcare partner. Our Values Listen~Love~Respect~Excel~Innovate This position shall act as a liaison between the hospital, clinical areas, and the Information Technology Department. This includes the primary responsibility of determining the needs and requirements for clinical applications in acute and ambulatory healthcare ancillary departments. The Clinical Informatics Specialist will also lead projects associated with the evaluation, selection, and implementation of clinical systems (i.e. EHR, PACS, digital imaging, etc.). This individual will work with staff and physicians to optimize the usage of clinical systems through education and training, quality outcomes, and providing support in accordance with organizational goals. The individual in this position will be required to fully understand the purpose and operation of Information Technology along with having the ability to make decisions based on sound judgment when a situation dictates. ESSENTIAL FUNCTIONS: - Responsible for planning, evaluating, and implementing extended training of staff for clinical information systems. Develops training materials and/or manuals for clinical information systems. - Develop and consistently update policy and procedures pertaining to use of clinical information systems, utilizing staff and manager feedback. Maintain knowledge of standards and ensure compliance with regulatory agencies. - Works closely with all Information Technology Department staff members and Clinical Informatics Specialists to ensure high quality IT products and services are provided throughout the organization. - Actively participate in performance improvement efforts for clinical areas as it pertains to clinical informatics. Collaborate with other departments to identify areas for improvement and efficiency. - Act as a liaison with clinical staff and medical staff to assess their system needs and provide information and training as needed. Provide day-to-day consultation and development support, interpret user problems and initiate the appropriate action for their resolution. - Facilitate planning for future direction of the Electronic Health Records (EHR) and related efforts, including requests for changes and enhancements to the current and future EHR systems. Direct and participate in computer training and orientation activities for current and new employees, students, and physicians. - Provide technical support to Samaritan Healthcare clinical areas, both at the hospital and physician clinic, regarding the use of software. Troubleshoot software problems and initiate corrective procedures. - Actively participate as a member of the Informatics Team and serve on other teams as requested. POSITION QUALIFICATIONS: - Graduate of accredited School of Nursing and current Washington State Registered Nurse License preferred or another clinical field with an associates degree and state licensure. - Current Washington State RN Licensure, preferred. - Basic Life Support Heartsaver (HS) level to be completed within 30 days of hire. - Two (2) to three (3) years experience with systems implementation and support preferred. COMPETENCIES: - Comprehensive understanding of clinical principles to evaluate information system needs. - Proficient with computers (MS Word, Excel, PowerPoint, Publisher, etc.). - Proficient with report writing software (Crystal Reports, etc.). - Excellent interpersonal, verbal, and written communication skills. - Excellent customer service skills. - Demonstrates competency on equipment listed on department specific checklist. - Critical thinking skills: Seeks resources for direction, when necessary. Performs independent problem solving. Decision-making is logical and deliberate. - Performs actions that demonstrate accountability. Exercises safe judgment in decision-making. Practices within legal and ethical guidelines. PHYSICAL REQUIREMENTS: - Occasional standing, walking, lifting, reaching, kneeling, bending, stooping, pushing and pulling. - Manual dexterity, light physical effort, ability to lift/.carry up to 50 lbs. (supplies, equipment). - Good reading eyesight. - Ability to communicate using verbal and/or written skills for accurate exchange of information with physicians, nurses, health care professionals, patients and/or family, and the public. As a Samaritan professional, you will be asked to carry out the Mission, Vision, Values, and Strategy of Samaritan, personifying service and operational excellence including the creation and maintenance of the best patient, professional, physician, and student experience.