Clinical Research Associate

Location: San Jose, CA

Circulation

Trial Responsibilities:

  • Provide support to the study team within the clinical affairs group.
  • Create, organize and maintain clinical files (Master/Project Files, Site Files, and Patient Files, Clinical Trial Agreements) and regulatory documents – electronic and physical files
  • Adhere to study execution strategy in order to meet business objectives
  • Perform study start-up and conduct activities including ICF review, IRB submissions, and those that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities
  • Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate gaps and non-compliance
  • Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal, FDA, and competent authority (e.g., DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations
  • Assess current processes, identify opportunities and propose solutions to improve process efficiency within the scope of work
  • Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
  • Assist with clinicaltrials.gov updates

Site Management: 

  • Skillfully develops, nurtures and maintains relationships with investigators, coordinators, and site staff with whom this individual works
  • Completion and review of monitoring reports, as needed
  • Facilitate negotiation and review of site agreements (NDAs, CTAs, BAs)
  • Assist sites with IRB/EC submissions
  • Collection and review of regulatory and medical source documents
  • Conduct and/or support site visits as needed.
  • Site payments creation, tracking and management
  • Investigational device disposition and tracking
  • Study supplies ordering and replacement
  • Updating of serious adverse events reports in collaboration with the Safety team for US and OUS reporting requirements
  • Provide sites protocol and device training remotely or in person as needed.
  • Field travel to sites as needed.
  • The CRA will be responsible for helping organize and track communications and study regulatory documents consistent with Good Clinical Practice (GCP), ICH Guidelines, 21 CFR (code of federal regulations) and company’s Standard Operating Procedures (SOPs). 
  • Support the development and modification of study level documentation, as needed.
  • Support the development and modification of study systems (e.g. EDC, CTMS, eTMF), as needed.
  • Planning and organization of investigators meetings and research coordinators meetings, as needed
  • Support audits of CROs and other outside vendors, as needed

General Responsibilities

  • Maintain up-to-date knowledge of global medical device regulations
  • Comply with ZOLL Circulation’s quality system requirements as well as any applicable regulatory requirements
  • Support organization's goals and values
  • Support departmental initiatives (e.g. revisions to SOPs, LEAN activities, etc…)
  • Confer with Clinical Affairs and other management staff regularly to review internal progress towards goals and objectives, as well as external conditions and required actions, mitigations, or changes needed.
  • Responsible for other duties and projects as assigned

Basic Qualifications

  • Knowledge of the FDA IDE/PMA regulations, GCP, ICH Guidelines, 21 CFR and ISO 14155.
  • Highly proficient with MS Office (Word, Excel, MS Project, Outlook, Visio and PowerPoint).
  • Knowledge of Electronic Data Capturing Systems, CTMS & eTMF Systems
  • Comprehensive understanding of medical terminology and familiarity with patient records and documentation.
  • Experience providing clinical training or support.
  • Experience in Cardiovascular and/or Stroke trials is a plus
  • While performing the duties of this job, the employee may be required to travel 25-30%

Education/Experience

  • Bachelor’s Degree in life sciences, medicine, nursing or other health related disciplines
  • 0-2 years of experience in a clinical research environment, either in the medical device or pharmaceutical industry or relevant experience in a medical/scientific area in a research institution.
  • The Certified Clinical Research Associate (CCRA) or Society of Clinical Research Associates (SOCRA) credential certification is preferred but not required.

Additional Skills and Abilities

  • Ability to work well with internal and external customers.
  • Creative problem solver coupled with good judgment.
  • High ethical standards
  • High attention to detail and accuracy.
  • Ability to manage and prioritize multiple tasks and remain focused on personal objectives with minimal direction.
  • Positive, flexible outlook.
  • Strong interpersonal communication skills with the ability to effectively communicate across all levels.
  • Proven ability to work effectively independently and in a multi-disciplinary team.
  • Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds clearly to questions
  • Writes clearly and informatively; presents effectively in a professional manner and appearance
  • Able to read and interpret medical, scientific and engineering literature
  • Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.  Takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990

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