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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.
Clinical Research Associate II- Shockwave Medical
Location
United States
Posted
88 days ago
Salary
$87K - $140K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Clinical Research Associate II- Shockwave Medical
Johnson & Johnson Innovative Medicine
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
Job Requirements
- 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
- 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
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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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• 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. 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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. 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DRG Denial Prevention Clinical Documentation Specialist
MultiCare Health SystemAt MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mission - partnering and healing for a healthy future - and dedicated to the health and well-being of the communities we serve.
You Belong Here. At MultiCare, we strive to offer a true sense of belonging for all our employees. Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe workplaces, and flexible schedules. We are connected by our mission - partnering and healing for a healthy future - and dedicated to the health and well-being of the communities we serve. FTE: 1.0, Shift: Day, Schedule: Day Position Summary The Diagnosis Related Grouping (DRG) Denial Prevention Clinical Documentation Specialist (CDS) is responsible for all Hospital Billing Clinical Documentation Integrity (HB CDI) across the system and serves as expert in the field. The incumbent is fully responsible for clinical related DRG denials; writes appeals, collects and analyzes denial data, educates staff on all areas of opportunity and works with CDI leadership across the MultiCare Health System to facilitate knowledge and proficiency in all aspects of HB CDI to assist leadership reach their department annual goals. Requirements - Bachelor's degree in Nursing, or obtained within three (3) years from the initial date of hire; RN with 25+ years of service may be considered in lieu of education agreement - Advanced Degree in Nursing (MSN, PhD, DNP, ARNP) preferred - Registered Nurse license (RN) in Washington State or multi-state licensure endorsement (MSL) - Minimum five (5) years of recent experience as a Clinical Documentation Specialist plus 5 years of Critical Care and/or Emergency Department clinical experience - Utilization Review or coding experience preferred Why MultiCare? - Rooted in the local community – Partnering with patients, families and neighbors across the Pacific Northwest for more than 140 years - Growth and education – Competitive tuition assistance, award-winning residencies, fellowships and career development to invest in your future - Well-being and support – Generous PTO, Code Lavender and Employee Assistance Programs to help you maintain balance and feel cared for at work and in life - Living our values – Respect, integrity, kindness and collaboration guide how we care for patients, communities and each other - Belonging for all – Employee Resource Groups, inclusion initiatives and outreach programs support a workplace where every voice is valued - Pacific Northwest lifestyle – Work and live where natural beauty, adventure and strong community connections are part of everyday life Pay and Benefit Expectations We provide a comprehensive benefits package, including competitive salary, medical, dental and retirement benefits and paid time off. As required by various pay transparency laws, we share a competitive range of compensation for candidates hired into each position. The pay scale is $112,674.00 - $183,810.00 USD. However, pay is influenced by factors specific to applicants, including but not limited to: skill set, level of experience, and certification(s) and/or education. If this position is associated with a union contract, pay will be reflective of the appropriate step on the pay scale to which the applicant’s years of experience align. Associated benefit information can be viewed here.
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as Associate Clinical Data Team Lead – 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 expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Associate Clinical Data Team Lead, you will act as the assistant lead data manager for one or more projects, supporting the lead data manager by performing assigned tasks in study setup, data cleaning, database close-out, and other associated tasks. What You’ll Do: • Applies relevant components of the project protocol to daily tasks with guidance. • Delivers study specific training to junior associates for assigned projects. • Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met with minimal supervision. • Assists with specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development. • Monitors for risks to deadlines and escalates appropriately. • Creates and maintains data management project documentation. • Participates in team and client meetings and supports the lead data manager with risk management on allocated projects. • Provides input into project forecasting of hours and identification of resource requirements. • Monitors study metrics and runs project-specific status reports for management. • Reviews data management deliverables for allocated projects following documented guidelines. • Produces project-specific status reports for management, PM and/or clients on a regular basis Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). 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: • Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail • Ability to apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations • Ability to work productively with support and minimal supervision • Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data • Strong customer focus and excellent interpersonal skills • Proven flexibility and adaptability • Ability to work in a team environment and independently as needed • Ability to train and direct junior team members • Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Occasional drives to site locations • Occasional travel both domestic and international. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.


