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Sr Clinical Research Associate (Sr. CRA) In-House

Location: San Jose, CA

Temperature Management

Overview

The Sr. CRA is responsible for assisting in managing and meeting the objectives of ZOLL Clinical Programs. The duties will be to support the daily in-house activities of the various clinical trials as well as case support/coverage in the field in instances where the clinical specialists are already booked.

 

 

Responsibilities

In-house responsibilities include, but they are not limited to:
Site Management including review of monitoring reports, review of site contracts, assist sites with IRB/EC submissions, completion of site checklist, collection and review of regulatory documents, 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. Orchestrate monitoring activities, including contributing to finalization of monitoring plan and coordination of monitoring visits scheduling. Management of Corelab, including tracking imaging and following up with sites to collect missing imaging.  The CRA will be responsible for helping organize and track communications and study regulatory documents consistent with Good Clinical Practice (GCP), ICH Guidelines, CRF 21 and company’ Standard Operating Procedures (SOPs). Planning and organization of investigators meetings and research coordinators meetings. Provide sites protocol and device training remotely or in person as needed.

Qualifications

Skill Requirements:

  • 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.

 

Conceptual Skills:

  • Ability to work well with internal and external customers.
  • Creative problem solver coupled with good judgment.
  • High ethical standards
  • Independent work skills.
  • 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.
  • Dependable.
  • 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.
  • Presents professional manner and appearance.

Education/Training/Experience Requirements:

  • Bachelor’s Degree in life sciences, medicine, nursing or other health related disciplines
  • Minimum of 5-7 years of experience in a clinical research environment, preferably in the medical devices or pharmaceutical industry or relevant experience in a medical/scientific area in a research institution.

 

Certificates and Licenses:
The Certified Clinical Research Associate (CCRA) credential certification is preferred.

 

Physical Requirements:
Position requires up to 30% travel.

 

Preferred Experience:
Experience in a Medical device environment preferred.

 

 

Equal Opportunity Employer – Disability and Veteran

 

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