• Review study documents to complete Cost and Coverage Analysis • Serve as a consultant on patient care items and services • Create study budgets for research activities • Negotiate study budgets ensuring compliance with Medicare rules • Ensure regulatory compliance with federal, state, and other governing entities

• 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.