[Remote] Clinical Research Associate II- Shockwave

Note: The job is a remote job and is open to candidates in USA. Shockwave Medical is a company focused on healthcare innovation, particularly in developing treatments for complex diseases. The Clinical Research Associate II will facilitate the setup, maintenance, and closure of global clinical trials while ensuring compliance with protocols and overall clinical objectives.ResponsibilitiesMay participate in study design and study set up activitiesMay conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conductMay prepare and/or review monitoring reports per SOPsSupports development of study training and may provide study site training to site personnelProvides study training to internal employees as applicableAssists in development of CRF design, CRF guidelines and supports database development when applicableDevelops study tools and guidelines to be utilized by study sitesDevelops basic knowledge of the process used to evaluate and select potential investigators and sitesDevelops basic knowledge of the process used to evaluate and select potential vendors as applicableInteracts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issuesMay perform data in clinical database for completeness, accuracy and performs data trending as neededMay analyze and evaluate clinical data gathered during researchDrafts informed consents as applicableReviews site’s informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revises as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understandCoordinates and reviews regulatory documents from study sites; ensures completeness and accuracyEnsures audit preparednessMay be responsible for tracking Safety Reports for assigned sitesResponsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reportsMay initiate device shipments to ensure that study supplies are adequate for assigned studies and accurately accounted throughout studyDevelops basic knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studiesMay be responsible for initiating and tracking quarterly site payments and reconciling study invoicesCommunicates status of trial to manager and teamMay be responsible for development or revision of SOPs or work instructionsAppropriately represents functional areaOther duties as assignedSkillsBachelor's degree in a scientific field of study, with a minimum of 2 years directly supporting clinical researchMust have excellent verbal and written communication skillsHigh attention to detail and organizational skills are necessaryAbility to travel 10-20% domestically and internationallyExperience with EDC Data Management SystemsAbility to work in a fast-paced environment while managing multiple prioritiesOperate as a team and/or independently while demonstrating flexibility to changing requirementsBasic understanding of peripheral and coronary artery disease and therapiesWorking knowledge of GCP, FDA, ISO and other applicable regulationsACRP or SOCRA clinical research certification preferredAnalytical ReasoningAnalytics DashboardsBusiness BehaviorClinical Data ManagementClinical Research and RegulationsClinical Trial DesignsClinical TrialsExecution FocusLaboratory OperationsMedical KnowledgeProcess OrientedProfessional EthicsProject Integration ManagementProject ManagementResearch and DevelopmentResearch EthicsTraining AdministrationBenefitsSubject 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.Vacation –120 hours per calendar yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearCompany OverviewShockwave Medical is a medical device company that develops Intravascular Lithotripsy (IVL) for treating calcified coronary diseases. It is a sub-organization of Johnson & Johnson Medtech. It was founded in 2009, and is headquartered in Fremont, California, USA, with a workforce of 1001-5000 employees. Its website is http://shockwavemedical.com.