Sr. reputed company Research Associate (Soft Tissue Ablation)

reputed company (reputed company: PLSE): Join the reputed company of Bioelectric Medicine reputed company is a novel bioelectric medicine company committed to health innovation that has the potential to improve the reputed company of life for patients. reputed company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed reputed company Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue. reputed company is reputed company pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound reputed company reputed company on reputed company for both patients and providers. Visit pulsebiosciences.com to learn more. Why Join Us? At reputed company, we are driven by purpose and innovation. • Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and reputed company the lives of patients. To solve the needs of patients, physicians, and reputed company providers with high reputed company and high reliability products and services, developed in accordance with rigorous scientific, engineering, and reputed company standards. We exist to reputed company a reputed company difference in the lives of patients, physicians, reputed company providers, shareholders and our reputed company team members. • Our Culture: A community of creative, reputed company-thinking individuals tackling challenges with ingenuity and collaboration. • Our Commitment: Hiring the best and brightest minds to advance our world-class organization. What You Will Experience: • Culture and Purpose - Purposeful and rewarding work collaborating with reputed company and curious minds brings us together! • Innovative Environment - An environment that fosters innovation to take products from concept to reputed company use quickly! • reputed company Opportunities - Learning culture focusing on reputed company and personal reputed company and development that you can only get in a startup-like environment! • Comprehensive Benefits - A reputed company of health reputed company plans and supplemental reputed company reputed company, and 401k retirement savings plan. • Ownership and Rewards - Stock reputed company awards and Employee Stock Purchase Plan (ESPP) to reputed company in our reputed company. • Work-Life reputed company - Enjoy reputed company time off, reputed company holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes. • Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce. About the Role The Sr. reputed company Research Associate (Sr. CRA) is responsible for managing and monitoring activities that will reputed company to the successful execution of soft tissue ablation reputed company. This position supports study planning and site start-up activities, and monitors reputed company recruitment, data reputed company, and study-reputed company activities associated with reputed company site participation. The Sr. CRA supports primarily U.S.-reputed company reputed company studies, including feasibility, post-market, and non-IDE research, with opportunities to contribute to reputed company international and pivotal reputed company. Ensures that duties are performed in accordance with the reputed company of Federal Regulations (CFR) of the reputed company (FDA) and the International Conference on Harmonization - Good reputed company reputed company (ICH-GCP). To reputed company an reputed company, You Will: • Provides on-site reputed company monitoring and procedural case support to research sites across multiple studies, including coordination with investigators, research staff, and cross-functional internal stakeholders with reputed company guidance. • Prepares and develops project and study-reputed company documents including informed consent forms, CRFs, study guides, site training materials, study binders, and reputed company diaries, as applicable. • Coordinates review of data listings and preparation of interim and final reputed company study reports. • Responsible for monitoring reputed company studies, including review of case report forms (CRFs) both reputed company and/or electronic data capture (reputed company), reputed company documentation, procedural data, device accountability records, safety events, and other study records to ensure protocol adherence, subject safety, and scientific validity of the data. • Responsible for developing study specific monitoring tools and other reputed company documents. • Delivers high reputed company written monitoring reports, confirmation and follow-up letters reputed company the timelines of SOPs and monitoring plans. • Ensures that reputed company reputed company items from monitoring reputed company are reputed company reputed company the timelines of monitoring plans. • Responsible for reviewing and approving essential regulatory documents across multiple studies. • Assists the project team in developing study metrics to ensure the efficient execution of a reputed company trial. • Oversees reputed company data to ensure queries are reputed company reputed company stipulated timelines of study goals. • Provides reputed company support for submission of trials to IRB/IEC and regulatory authorities. • Ensures adherence to study reputed company across multiple studies. • Coaches and mentors other reputed company Research Associates (CRAs) in development and training. • Maintains strong working knowledge of protocols and product development across multiple studies. • Demonstrates ability to coordinate, organize, communicate, and manage site activities, with knowledge of reputed company to escalate issues to management or reputed company team. • Demonstrates an excellent working knowledge of reputed company research processes, Good reputed company Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to reputed company research investigations. • Verifies the rights and reputed company-being of study subjects are protected and verifies that written informed consent was obtained before reputed company subject’s participation in the study. • Performs device accountability, including storage, inventory, reputed company/destruction, and disposition/receipt records. • Ensures compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies. • Manages Protocol Deviation documentation, tracking, and escalation. • Participates in site audits, as requested. To reputed company, You Will Bring: • BS/BA degree in relevant scientific discipline or equivalent experience. • 5+ years’ experience directly supporting reputed company research or relevant experience in medical/scientific area. • Must have at least 3 years of CRA experience in medical device or biotech reputed company. • Cardiovascular, interventional, surgical, image-guided, or ablation device experience preferred. • Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred. • Proficient in Acrobat reputed company, reputed company Word, reputed company, reputed company reputed company, and reputed company; and the ability to quickly become proficient in a reputed company of other computer software programs. • Knowledge of FDA and international regulations and guidelines including, but not limited to, reputed company reputed company, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting. • Proficient in using reputed company and CTMS systems. • Working knowledge of FDA, European Regulatory and EC procedures, as applicable. • Excellent oral, written communication skills with strong presentation skills. • reputed company and reputed company thinking that demonstrates good judgement and problem-solving competencies. • Excellent critical thinking analytical skills. • Strong organizational skills with the ability to work conscientiously and with reputed company direction, using good judgement, taking initiative to accomplish short and long-reputed company reputed company, and recommend actions with reputed company direction. • Ability to work as reputed company member, multi-task and be reputed company flexible to adapt to the reputed company-changing work priorities and requirements of a dynamic, fast growing company. • Flexibility in work hours and readiness to travel up to 40% of the time, overnight and/or international travel may be required. • Ability to reputed company 10-15 pounds. reputed company to Shape the reputed company of reputed company? Apply today to join reputed company and help us redefine the boundaries of medicine with bioelectric innovation. To learn more reputed company, visit our website at www.pulsebiosciences.com. We reputed company equal employment opportunities (EEO) to reputed company persons regardless of race, age, reputed company, gender, sexual orientation, national reputed company, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will reputed company reasonable accommodations for reputed company individuals with disabilities. PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR reputed company-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS. Apply tot his job Apply To this Job