• Lead end-to-end clinical trial execution, ensuring delivery against timelines, quality standards, and budget • Provide operational oversight of site management and monitoring activities, including on-site and centralized monitoring • Identify, assess, and proactively mitigate clinical and operational risks using a risk-based management approach (RACT) • Serve as the primary escalation point for CRAs, investigative sites, and cross-functional stakeholders • Partner closely with Study Start-Up, Data Management, Biostatistics, Safety, and Patient Recruitment teams to drive milestone achievement • Leverage integrated systems and data (CTMS, EDC, ePRO, TMF, dashboards) to monitor performance, trends, and risk indicators • Ensure ongoing inspection readiness and compliance with ICH-GCP, SOPs, and global regulatory requirements • Lead study-specific training and foster alignment across the clinical trial team • Review metrics and operational data to anticipate challenges and implement timely solutions • Mentor and support CRAs, contributing to a culture of accountability, continuous improvement, and collaboration

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial • Lead cross-functional study execution team in support of study deliverables • Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership • Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs • Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews • Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files • Negotiate and finalize site contracts and budgets • Manage clinical trial budgets, providing ongoing financial reporting and projections • Perform and manage data review process on an ongoing basis • Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed • Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues.

Job DetailsJob Location: Portage, IN 46368 Summary/ Objective The Clinical Operator acts as a liaison between the patient and their medical provider by evaluating the main issue or primary complaint. The Clinical Operator uses focused, evidence-based triage protocols to determine urgency and provide suitable care guidance and suggestions for next steps. Essential Functions Receive calls from patients requesting to speak to a member of their medical team, and routes calls to the appropriate care team member Send tasks in the electronic medical record for medication refills, referrals, and other patient requests to their providers Displays outstanding customer service and communication abilities and the capacity to work as part of a highly productive team that is consistently patient centered Establishes positive first impressions with patients, establishing a role as an advocate Reviews and assesses all incoming phone calls and electronic messages, prioritizing and addressing them as needed. Involve the provider when appropriate to successfully complete the communication process Utilizes critical thinking to create, put into action, and revise an individualized care plan based on the identified patient care and learning requirements Asks key questions to gain insight into the patient’s condition or concern and able to adjust approach as needed to get necessary information Document all communications in the electronic medical record Follows triage protocols in place for the department Assist in scheduling appointments for patients with providers Uses effective service recovery skills to solve problems or service breakdowns when they occur Maintains HIPAA standards and confidentiality of protected health information. Perform other duties as assigned. *These essential functions are a summary of the primary duties and responsibilities of the position and are not intended to be a comprehensive listing of all duties and responsibilities. The position will include other duties as assigned and duties are subject to change at the management's discretion. Competencies Planning and strategic foresight Responsible Decision Making and Problem Solving Integrity and accountability Innovation and creativity Adaptive and flexible Leadership, teamwork, and conflict resolution Professionalism and work ethic Empathy Work Environment Work is performed in an office environment. Involves frequent personal and telephone contact with patients, physicians, and other healthcare personnel. Work may be stressful at times. Interaction with others is constant and interruptive. Travel Travel outside of Northshore locations will be rare for this position. This position is remote. Qualifications Required Role Qualifications Minimum required education per state of Indiana/HRSA Certified/Registered Medical Assistant, Licensed Practical Nurse, Advanced Practical Nurse or Registered Nurse licensing Preferred Role Qualifications Two years of experience working within a healthcare setting. Bilingual preferred Required experience (if any) Required Skills Ability to analyze situations and solve problems at strategic and tactical levels Excellent interpersonal and customer service skills Ability to comprehend, interpret, and apply the appropriate sections of applicable laws, guidelines, regulations, ordinances, and policies Ability to acquire a thorough understanding of the organization's hierarchy, jobs, qualifications, compensation practices, and the administrative practices related to those factors Practiced at organization and planning Employ Critical thinking and problem solving Maintains composure and operates with emotional intelligence Ethical reasoning and decision-making Strong attention to detail Receptive and responsive to feedback Excellent verbal and written communication skills Time management, prioritization, and sense of urgency Proficient with Microsoft Office Suite or related software Physical, Visual, and Audible Requirements Physical Requirements Activity Occasionally (1 -33%) Frequently (34-66%) Continuously (67-100%) Sitting X Walking X Standing X Bending X Squatting/ Crouching X Climbing X Kneeling X Twisting/Turning X Hand dexterity/Fine Motor Manipulation X Lifting 0 – 50lbs X Lifting 50+lbs X Carrying 0 – 50lbs X Carrying 50+lbs X Pushing 0 – 300lbs X Visual & Audible Requirements – Employee mark an “x” for “YES” or “NO” Activity Yes No Can see without corrective eyewear Can differentiate colors/see color differences clearly Can hear without hearing assistance I acknowledge that I may be exposed to infectious and contagious diseases. I acknowledge that I may be in contact with patients under a wide variety of circumstances. I acknowledge that I can handle and respond to emergency or crisis situations per NorthShore Health Centers facility plans, protocols, and procedures. I acknowledge that I may occasionally be subject to irregular working hours. I acknowledge that I may be required to wear personal protective equipment (PPE) as necessary. *Reasonable accommodations can be made to enable people with disabilities to perform the essential functions of the job described.

CRA - Chile 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 Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. What You Will Be Doing: - 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. Your Profile: - Advanced degree in a relevant field such as life sciences, nursing, or medicine. - Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. - Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills. - Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools. - Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment. - Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license 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