Field Research Specialist

Research AnalystResearch AnalystFull TimeRemoteTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

California + 5 moreAll locations: California, Florida, Illinois, New York, Massachusetts, Texas

Posted

3 days ago

Salary

$96K - $155.3K / year

Bachelor Degree5 yrs expEnglish

Job Description

• Provides field support for clinical research related enrollment and procedures • Serve as a technology, protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site • Develop and maintain in depth knowledge of clinical trial sites • Understand and assess investigators’ interests and qualifications • Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code • Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel • Proactively and critically examine ways to enhance overall clinical trial performance • Facilitate communication between clinical trial sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed • Manage the following aspects of study progress, including, but not limited to: Start Up o Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution • Facilitate contract/budget escalations as part of the start-up process • Train facility staff regarding protocol requirements and technology • Develop site-specific strategies to promote appropriate patient enrollment • Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement • Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives • Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc. • Provides on call, bedside clinical trial case coverage for multiple clinical trials and clinical trial sites • Provides back up support in the following areas, trouble shooting, in-service training to physicians and healthcare professionals • Responsible for product reporting and troubleshooting with customers and field personnel within the clinical research portfolio • Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training • Identify and communicate best practices relevant to clinical trial execution • Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities • Collaborate with Clinical Affairs, Medical Affairs, R&D, marketing, and commercial teams to support and advance key projects • Serve as a scientific interface with healthcare professionals • Act as resource in corporate product education as it relates to investigative technologies, as necessary • Develop collaborative cross-divisional team relationships • Provides engineering, education and clinical support in response to field-based inquiries on as needed basis • Transfers clinical trial knowledge and experience into meaningful input and feedback to cross functional partners in R&D, medical affairs, marketing, sales, and education • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Job Requirements

  • Bachelor’s degree in engineering, nursing, biological sciences, a related field, equivalent or related certification in cardiology
  • 5 years of relevant clinical experience, with in-depth knowledge of cardiology, and related cardiovascular technologies
  • Direct patient support in Cath lab and operating room is a plus
  • Availability for to work on call for emergent clinical trial support required
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to leverage and/or engage others to accomplish projects
  • Advanced verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Required clinical research experience in medical devices
  • Knowledge of Good Clinical Practices and trials, including feasibility IDE
  • Multitasks, prioritizes, and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to travel approximately 70% domestically.

Benefits

  • medical, dental, vision, life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • car allowance through the Company’s Fleet program
  • consolidated retirement plan (pension)
  • savings plan (401k)
  • long-term incentive program
  • up to 120 hours vacation per calendar year
  • up to 40 hours sick time per calendar year
  • up to 13 days holiday pay per calendar year
  • up to 40 hours Work, Personal and Family Time per calendar year

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