Clinical Safety Specialist II

4 weeks ago


Minneapolis, Minnesota, United States Shockwave Medical Full time
Job Description

Shockwave Medical is a leading medical device company revolutionizing the treatment of advanced cardiovascular disease. We are seeking a highly skilled Clinical Safety Specialist II to join our team.

The Clinical Safety Specialist II will be responsible for ensuring the safe and effective use of our medical devices. This includes collecting and managing adverse event reports, collaborating with investigative sites and Contract Research Organizations (CROs), and ensuring compliance with regulatory requirements.

The ideal candidate will have a strong background in clinical research, with experience in adverse event management and medical device regulations. They will possess excellent communication and organizational skills, with the ability to work independently and as part of a team.

Key Responsibilities:

  • Collect and manage adverse event reports
  • Collaborate with investigative sites and CROs
  • Ensure compliance with regulatory requirements
  • Assist with preparation for Clinical Events Committee (CEC) meetings and Data Safety Monitoring Board (DSMB) meetings
  • Perform and/or assist Data Management with database reconciliations
  • Ensure quality and accuracy of site-reported safety information

Requirements:

  • RN or equivalent healthcare experience with a life-sciences Bachelor's degree preferred
  • Minimum 2+ years' experience of clinical research experience
  • Experience including clinical safety adverse events management, cardiovascular disease and medical device clinical studies is preferred
  • Strong written, oral, and interpersonal communication skills
  • Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
  • Good prioritization and organizational skills
  • High attention to detail and degree of accuracy

Benefits:

  • Competitive total compensation package
  • Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match
  • Short-Term and Long-Term Disability, and Life Insurance
  • Employer contribution toward Health Savings Account (HSA)
  • Competitive PTO balance

Perks:

  • Calm App
  • Pet Insurance
  • Student Loan Refinancing
  • Spot Bonus awards


  • Minneapolis, Minnesota, United States Shockwave Medical Full time

    Job Title: Clinical Safety Specialist IIAt Shockwave Medical, we are revolutionizing the treatment of advanced cardiovascular disease. We are seeking a highly skilled Clinical Safety Specialist II to join our team.Job Summary:The Clinical Safety Specialist II will be responsible for the collection and management of adverse event data for clinical studies....


  • Minneapolis, Minnesota, United States Children's Minnesota Full time

    About Children's MinnesotaChildren's Minnesota is a leading pediatric health system in the United States, dedicated to providing exceptional care to children from birth through young adulthood. As a not-for-profit organization, we prioritize innovation, quality, and patient safety in all aspects of our care.Position Summary* The Clinical Education Specialist...

  • Safety Engineer II

    4 weeks ago


    Minneapolis, Minnesota, United States Mortenson Full time

    About the RoleMortenson is seeking a highly skilled and experienced Safety Engineer II to join our Solar Group team. As a key member of our safety team, you will be responsible for implementing and administering Mortenson's Zero Injury Safety program at project sites, ensuring a safe work environment for team members, subcontractors, and visitors.Key...


  • Minneapolis, Minnesota, United States Bayone Full time

    Job Title: Phlebotomy Specialist IIJob Summary: We are seeking a skilled Phlebotomy Specialist II to join our team at Bayone. As a Phlebotomy Specialist II, you will be responsible for drawing quality blood samples from patients and preparing those specimens for lab testing while following established practices and procedures.Key Responsibilities:Draw blood...


  • Minneapolis, Minnesota, United States City of Minneapolis Full time

    Job SummaryWe are seeking a highly skilled Fire Safety Specialist to join our team at the City of Minneapolis. As a Fire Safety Specialist, you will be responsible for conducting complex fire and life safety inspections of commercial, industrial, and institutional facilities, as well as multi-unit residential properties. You will also be responsible for...


  • Minneapolis, Minnesota, United States City of Minneapolis, MN Full time

    Job Title: Fire Inspections Specialist IIJoin the City of Minneapolis, MN team as a Fire Inspections Specialist II. This role involves conducting complex fire and life safety inspections of commercial, industrial, and institutional facilities, as well as multi-unit residential properties. You will verify, document, and enforce compliance with Minneapolis...


  • Minneapolis, Minnesota, United States US Tech Solutions Full time

    Electrical Design Specialist II Job Description **Job Summary** US Tech Solutions is seeking an experienced Electrical Design Specialist II to join our team. As an Electrical Design Specialist II, you will be responsible for designing and drafting electrical and mechanical aspects of electrical/electronic equipment. **Key Responsibilities** * Design and...


  • Minneapolis, Minnesota, United States Aramark Full time

    Clinical Nutrition Manager II Job DescriptionThe Clinical Nutrition Manager II is responsible for planning, coordinating, and managing all patient/resident nutrition care activities while ensuring compliance with established standards.This includes developing and implementing cost-effective, profit-generating nutrition programs, collaborating with the...

  • Support Specialist II

    4 weeks ago


    Minneapolis, Minnesota, United States Pathways to Community Full time

    About the Role:We are seeking a dedicated and compassionate Support Specialist II to join our team at Pathways to Community. As a Support Specialist II, you will play a vital role in supporting individuals with daily needs, including personal care, training new staff, administering medications, cooking, and providing constant...


  • Minneapolis, Minnesota, United States US Tech Solutions Full time

    Electrical Design Specialist IIAt US Tech Solutions, we are seeking an experienced Electrical Design Specialist II to join our team. The successful candidate will be responsible for designing and drafting electrical and mechanical aspects of electrical/electronic equipment.The ideal candidate will have a strong understanding of Creo CAD modeling, design, and...


  • Minneapolis, Minnesota, United States C4 Technical Services Full time

    Ecommerce Specialist IIThis role involves executing brand-level and product-level ecommerce execution plans, including product presence, demand generation, and analytics to maximize execution of pre-defined ecommerce plans. The candidate will have substantial input into future ecommerce plans by delivering metrics and recommendations that help define the...


  • Minneapolis, Minnesota, United States City of Plymouth, MN Full time

    Job Summary: We are seeking a highly motivated and experienced lifeguard to join our team as a Pool Safety Specialist. As a Pool Safety Specialist, you will be responsible for ensuring the safety and well-being of pool users. This includes monitoring pool activities, identifying safety issues, and providing support to participants and...


  • Minneapolis, Minnesota, United States YWCA Minneapolis Full time

    Aquatic Safety SpecialistAt YWCA Minneapolis, we are seeking an Aquatic Safety Specialist to join our team. As a Lifeguard and Aquatics Facility Supervisor, you will be responsible for recognizing and responding effectively to all emergency situations and customer service needs in the aquatics facility. You will supervise, control, and help maintain the pool...

  • Safety Specialist

    3 weeks ago


    Minneapolis, Minnesota, United States M. A. Mortenson Full time

    Job Summary:Mortenson is seeking a highly skilled Safety Specialist to join our team. As a key member of our safety team, you will be responsible for ensuring a safe work environment for our team members, subcontractors, and visitors. Your primary focus will be on implementing and maintaining our Zero Injury program, which aims to eliminate workplace...


  • Minneapolis, Minnesota, United States Kurita Group Full time

    Kurita America, a leading water solutions provider, seeks an Environmental Health and Safety Specialist to join their team in Brooklyn Park, MN. As a shared resource between Microelectronics Production and the Environmental, Health, and Safety team, this role will ensure safe operations on the production floor and perform safety-related duties as assigned by...


  • Minneapolis, Minnesota, United States City of Minneapolis Full time

    Job Title: Family Support Specialist IIJob Summary:The City of Minneapolis is seeking a highly skilled and motivated Family Support Specialist II to join our team. This role will be responsible for providing support and guidance to individuals and families in need, while also contributing to the development and implementation of programs and services that...

  • Fire Safety Inspector

    4 weeks ago


    Minneapolis, Minnesota, United States City of Minneapolis Full time

    Job SummaryWe are seeking a highly skilled Fire Inspections Specialist II to join our team at the City of Minneapolis. As a key member of our Fire Inspection Services team, you will be responsible for conducting complex fire and life safety inspections of commercial, industrial, and institutional facilities, as well as multi-unit residential properties.Key...


  • Minneapolis, Minnesota, United States Minnesota Visiting Nurse Agency Full time

    Job Summary:We are seeking a skilled Coding Specialist II to join our Hospital Billing OP Coding team. This full-time role will primarily work remotely, with the opportunity to contribute to the success of our organization.Key Responsibilities: Assign the appropriate ICD, HCPCS/CPT, and E&M codes to diagnoses and procedures generated for outpatient or...


  • Minneapolis, Minnesota, United States League of Minnesota Cities Full time

    Job SummaryThe City of Minneapolis is seeking a highly skilled Family Support Specialist II to manage the Step Up Program. This role involves researching employment and training issues, planning and evaluating programs, developing grants and contracts, managing budgets and finances, and advocating for employment and training-related issues.Key...


  • Minneapolis, Minnesota, United States ASM Global Full time

    Job Summary:As a Public Safety Specialist at ASM Global, you will be responsible for enforcing security protocols and maintaining public safety during events. This includes patrolling assigned areas to deter criminal activity and responding to emergencies. You will also investigate incidents, gather evidence, and file detailed reports. Additionally, you will...