• 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

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with a high employer contribution - Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we’ve been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what’s possible in an evolving and challenging EP landscape. When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer, fuller lives. We are committed to building a foundation for our people to be successful, investing in their development and growth, and creating a diverse, inclusive culture that welcomes different perspectives, experiences and backgrounds. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. As a Clinical Associate on the U.S. Abbott EP team, you will provide clinical and technical support in a hospital setting, utilizing EP technology in the treatment of various cardiac arrhythmias. You will join a high-functioning, collaborative team, partnering closely with physicians and hospital staff to support the diagnosis and treatment of abnormal heart rhythms to achieve better patient outcomes. In this role, individuals will exercise independent judgment in planning, organizing, and performing day-to-day tasks. You will identify and routinely use the most effective, cost-efficient, and best business practices to execute processes, regularly communicating insights, feedback, and results to managers and team. Additional responsibilities include: - Gaining foundational knowledge of EP through a structured training program with a strong emphasis on hands-on learning and practical application. - Providing regional EP procedural case coverage in an Electrophysiology lab and/or operating room setting. - Acting as a clinical interface between the medical community and the business. - Demonstrating the ability to build and sustain credible clinical relationships with customers and sharing product expertise accordingly. - Demonstrating a thorough command of all EP products, including technical details, software utilization, and capabilities. - Providing engineering, sales, education, and clinical support on the safe and effective use of Abbott EP products, including cardiac mapping, diagnostic, and therapy systems. - Supporting EP Sales Representatives in the following areas: - Collaborating with sales personnel; - Facilitating regional training seminars; - Participating in clinical studies/data collection; - Troubleshooting; and, - Leading/supporting new product in-service trainings and/or demonstrations to physicians, nurses, and sales representatives. - Continuously develops engineering, sales and technical skills aligned with the overall territory strategy, including learning from senior sales personnel and management. - Staying up-to-date on the latest industry developments, regulatory requirements, and maintains strong knowledge of company and competitor products, market trends, and strategic goals. - Providing management with feedback on market trends and customer insights to inform strategic decisions and guide next-generation product development. - Participating in occasional travel for in-person instruction and live procedure coverage. Required Qualifications - Bachelors Degree or equivalent experience. - Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s). Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $50,700.00 – $101,300.00In specific locations, the pay range may vary from the range posted. JOB FAMILY: Support Services DIVISION: EP Electrophysiology LOCATION: United States of America : Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: Yes SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf