[Remote] Sr. Clinical Research Associate (Cardiac Catheter Products)

Note: The job is a remote job and is open to candidates in USA. Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Sr. Clinical Research Associate will be responsible for managing and monitoring clinical studies, ensuring compliance with regulations, and supporting research sites in their clinical trial activities.ResponsibilitiesProvide case support to research sites across multiple studies with minimal guidancePrepare and develop project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diariesCoordinate review of data listings and preparation of interim and final clinical study reportsBe responsible for monitoring clinical studies, which includes review of case report forms (CRFs) both paper and/or electronic data capture (EDC), and source documentation to ensure adherence to the protocol and scientific validity of the dataBe responsible for developing study specific monitoring tools and other related documentsDeliver high quality written monitoring reports, confirmation and follow-up letters within the timelines of SOPs and monitoring plansEnsure that all missing action items (MAIs) from monitoring visits are closed within the timelines of monitoring plansBe responsible for reviewing and approving essential regulatory documents across multiple studiesAssist the project team in developing study metrics to ensure the efficient execution of a clinical trialOversee clinical data to ensure queries are closed within stipulated timelines of study goalsProvide clinical support for submission of trials to IRB/IEC and regulatory authoritiesEnsure adherence to study timeline across multiple studiesCoach and mentor other Clinical Research Associates (CRAs) in development and trainingMaintain strong working knowledge of protocols and product development across multiple studiesDemonstrate ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical teamDemonstrate an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigationsVerify the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the studyPerform Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt recordsEnsure compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agenciesManage Protocol Deviation documentation, tracking, and escalationParticipate in site audits, as requestedSkillsBS/BA degree or equivalent experience5+ years' experience directly supporting clinical research or relevant experience in medical/scientific areaAt least 3 years of CRA experience in device or biotech clinical trialsProficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and Smartsheet; and the ability to quickly become proficient in a variety of other computer software programsKnowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reportingProficient in using EDC and CTMS systemsWorking knowledge of FDA, European Regulatory and EC procedures, as applicableExcellent oral, written communication skills with strong presentation skillsClear and systematic thinking that demonstrates good judgment and problem-solving competenciesExcellent critical thinking analytical skillsStrong organizational skills with the ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal directionAbility to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing companyFlexibility in work hours and readiness to travel 30%-50% of the time, overnight and/or international travel may be requiredAbility to lift 10-15 poundsCardiovascular device experience preferredCertified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferredBenefitsA variety of health insurance plans and supplemental insurance options401k retirement savings planStock options awards and Employee Stock Purchase Plan (ESPP) to share in our successPaid time offPaid holidaysFlexible work scheduleWellness program, including onsite gym and mindfulness classesCompany OverviewPulse Biosciences is the inventor and sole proprietor of Nanosecond Pulsed Field Ablation™ (nsPFA™) technology. It was founded in 2014, and is headquartered in Hayward, California, USA, with a workforce of 51-200 employees. Its website is http://www.pulsebiosciences.com/.Company H1B SponsorshipPulse Biosciences, Inc. has a track record of offering H1B sponsorships, with 1 in 2024, 1 in 2023, 2 in 2022, 1 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.