Role Description This role collaborates closely with the leadership of Clinical Affairs to execute clinical research strategy activities and oversee aspects of clinical trials in support of clinical evidence generation strategies across the GIS - Gastrointestinal Solutions Division; GI (including core GI, EUS, and Infection Prevention), EndoTherapy, Medical Service, and Endoscopic Solutions Ecosystem. This individual will participate in the development, execution, and closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus’s portfolio. Specifically, this individual will be responsible for: - Writing clinical study protocols, case report forms, and study reports. - Working closely with study sites to obtain necessary approvals (EC/IRB). - Responding critically to questions raised throughout the clinical study execution. The individual is a critical member of the Clinical Affairs strategy team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across different business units, and within the broader Olympus organization, as appropriate. Qualifications - BA/BS degree in life sciences or related field. - Minimum of 8 years medical device industry experience post-degree preferably in Clinical Affairs/Operations, Medical Affairs within medical device industry. - Experience working on clinical research evidence generation strategies. - Ability to think strategically, critically analyze and synthesize complicated data and scientific information. - Demonstrated scientific writing ability. - Ability to plan and organize project assignments of substantial variety and complexity. - Ability to be innovative, resourceful, and work with minimal direction. - Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. - Demonstrated ability to engage with external stakeholders; build and maintain relationships with key opinion leaders, investigators, and research staff. - Strong organizational and follow-up skills, as well as attention to detail. - Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration. - Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required. - Domestic and international travel up to 5-10%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships. - Scheduling flexibility to commit to a global weekly schedule (Tuesday – Wednesday – Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings. Requirements - Advanced degree in life sciences, medicine or related field (preferred). - Clinical research study design in the field of endoscopic therapy or minimally invasive medical technologies (preferred). Benefits - Competitive salaries, annual bonus and 401(k)* with company match. - Comprehensive medical, dental, vision coverage effective on start date. - 24/7 Employee Assistance Program. - Free live and on-demand Wellbeing Programs. - Generous Paid Vacation and Sick Time. - Paid Parental Leave and Adoption Assistance*. - 12 Paid Holidays. - On-Site Child Daycare, Café, Fitness Center**.

• Manage external vendors and contract research organizations • Assist with protocol development and study report completion • Plan and participate in investigator meetings • Maintain the trial master file

Title: Registered Nurse (RN) Clinical Reimbursement Specialist | Long-term care Full time Location: Avera at Home Sioux Falls Worker Type: Regular Work Shift: Day Shift (United States of America) Pay Range: The pay range for this position is listed below. Actual pay rate dependent upon experience. $78,000.00 - $116,480.00 Position Highlights Hybrid position with some travel involved Job Description: You Belong at Avera Be part of a multidisciplinary team built with compassion and the goal of Moving Health Forward for you and our patients. Work where you matter. A Brief Overview Responsible for ensuring accurate clinical documentation, assessment and Minimum Data Set ("MDS") coding to support appropriate reimbursement. This role blends strong clinical expertise with regulatory knowledge and analytical skills. This role will oversee compliance, accuracy and optimization of clinical reimbursement strategies for the LTC Division as well as clinical reimbursement compliance and overarching MDS support to teams across Avera. What you will do - Maintains knowledge of federal regulations, practice standards, and procedures, as well as guidelines pertaining to the RAI process. Develop division strategies for maximizing reimbursement for PDPM, Managed Care and other payer models. - Utilizes clinical judgement and nursing process to be a resource for Nurse Assessment Coordinators, Interdisciplinary team members and LTC Leaders. Develops strategies for maximizing reimbursement under PDPM, Managed Care and other payer models. - Partners with payor contracting on Managed Care/ACO contract utilization and ensures facilities adhere to payer guidelines, timely filing requirements, and pre-authorization processes. - Audits and implements action plans to improve staff education/competency as needed to ensure accurate and timely completion of supporting documentation and MDS assessment. - Monitors facility schedules for timely and complete MDS data submission as per Federal, State, and other payor requirements. - Analyzes reimbursement trends, identify deviations, implement corrective action plans through utilization of system data and analytic resources. - Acts as a liaison between facilities, finance, MDS, nursing, and system resources to ensure accurate reimbursement levels. - Provides ongoing operational support and guidance to facilities regarding denial management, appeals, and reimbursement strategies. - Leads the division efforts to implement best practices for accurate capture of the data elements of the Minimum Data Set (MDS), which is the key driver of the care plan, quality measures and reimbursement programs. - Must be willing to travel. Essential Qualifications The individual must be able to work the hours specified. To perform this job successfully, an individual must be able to perform each essential job function satisfactorily including having visual acuity adequate to perform position duties and the ability to communicate effectively with others, hear, understand and distinguish speech and other sounds. These requirements and those listed above are representative of the knowledge, skills, and abilities required to perform the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions, as long as the accommodations do not cause undue hardship to the employer. Required Education, License/Certification, or Work Experience: - Registered Nurse (RN) - Board of Nursing An active license in the state of practice Upon Hire and - Resident Assessment Coordinator - Certified (RAC-CT) - American Association of Post-Acute Care Nursing (AAPACN) An active certification by AAPACN or another approved certification agency to ensure knowledge of clinical assessment and care planning, completion of the MDS, and the regulatory body surrounding the RAI/MDS process within 180 Days - Strong leadership and communication skills with the ability to train and mentor teams Preferred Education, License/Certification, or Work Experience: - Bachelor's - Extensive knowledge of Medicare, Medicaid, PDPM, Managed Care, QM, and CMI reimbursement systems - Strong expertise in MDS processes, including completion, regulatory compliance - Regional MDS experience - Proficiency in analyzing reimbursement trends, auditing, and implementing performance improvements Expectations and Standards - Commitment to the daily application of Avera’s mission, vision, core values, and social principles to serve patients, their families, and our community. - Promote Avera’s values of compassion, hospitality, and stewardship. - Uphold Avera’s standards of Communication, Attitude, Responsiveness, and Engagement (CARE) with enthusiasm and sincerity. - Maintain confidentiality. - Work effectively in a team environment, coordinating work flow with other team members and ensuring a productive and efficient environment. - Comply with safety principles, laws, regulations, and standards associated with, but not limited to, CMS, The Joint Commission, DHHS, and OSHA if applicable. Benefits You Need & Then Some Avera is proud to offer a wide range of benefits to qualifying part-time and full-time employees. We support you with opportunities to help live balanced, healthy lives. Benefits are designed to meet needs of today and into the future. - PTO available day 1 for eligible hires. - Up to 5% employer matching contribution for retirement - Career development guided by hands-on training and mentorship

Title: Sr Clinical Research Associate - Central/West Coast Location: Morrisville United States Job ID: 25107626-OTHLOC-1500-2DNV-2DR Description Sr Clinical Research Associate - Central/West Coast Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned. - May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close out Knowledge of local requirements for real world late phase study designs Chart abstraction activities and data collection As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff Identify and communicate out of scope activities to Lead CRA/Project Manager Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Identify operational efficiencies and process improvements Develop country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings Qualifications: - Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected. - Ability to manage required travel of up to 75% on a regular basis At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline, understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.