At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Clinical Research Associate II– Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up, activation, maintenance and closure of global clinical trials while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives. In collaboration with the Clinical Research Manager, the CRA II maintains consistent CRF data quality and discrepancy interpretation across sites. The CRA II will develop a basic understanding of the disease and indication. Essential Job Functions - May participate in study design and study set up activities - May conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct - Participate in the review of monitoring visit reports for completeness - Supports development of study training and may provide study site training to site personnel - Provides study training to internal employees as applicable - Assists in development of CRF design, CRF guidelines and supports database development when applicable - Develop study tools and guidelines to be utilized by study sites - Develops basic knowledge of the process used to evaluate and select potential investigators and sites - Develops basic knowledge of the process used to evaluate and select potential vendors as applicable - Interacts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues - Drafts informed consents as applicable - Reviews site’s informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revisions as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand - Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy, facilitates translation as needed - Ensure study records are auditable in-house - Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports - Develops basic knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies - May be responsible for initiating and tracking quarterly site payments and reconciling study invoices - Communicates status of trial to manager and team - May be responsible for development or revision of SOPs or work instructions - Appropriately represents functional area - Other duties as assigned Qualifications - Bachelor’s degree in science or healthcare with a minimum of 2 years of medical device industry experience directly supporting clinical research in a Sponsor role - Must have excellent verbal and written communication skills - High attention to detail and organizational skills are necessary - Basic understanding of peripheral and coronary artery disease and therapies preferred - Working knowledge of GCP, FDA, ISO and other applicable regulations - Ability to travel 10-20% domestically and internationally - Experience with EDC Data Management Systems - Ability to work in a fast-paced environment while managing multiple priorities - ACRP or SOCRA clinical research certification preferred - Operate as a team and/or independently while demonstrating flexibility to changing requirements Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration The anticipated base pay range for this position is : $87,000.00 - $140,300.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do: • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. Identifies potential • investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. • Contributes to other project work and initiatives for process improvement, as required. Education and Experience Requirements: • Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. • Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Proven clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Ability to remain flexibile and adaptable in a wide range of scenarios • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills • Good presentation skills Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions Compensation and Benefits The salary range estimated for this position based in New Jersey is $66,800.00–$112,938.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: - A choice of national medical and dental plans, and a national vision plan, including health incentive programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

• Lead and contribute to the design of phase I-III clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures. • Lead and contribute to the development of clinical trial protocols and clinical study reports; write statistical methodology section of these documents. • Develop and prepare statistical analysis plans, statistical output shells, and analysis dataset specifications. • Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs. • Contribute to the electronic submission of clinical trial data to regulatory authorities. • Proactively solve problems of statistical complexity. • Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions). • Participate effectively as a key member on clinical study teams. • Provides analytical insight on statistical methodology and advice to internal teams of accordingly. • Keep current with new clinical trial designs and statistical methodology. • As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. • Train junior staff in more complex statistical methodology. • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

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