Senior Safety Specialist (RN)
AtriCure, Inc - West Chester, OH

This job posting is no longer available on Indeed. Find similar jobs: Senior Safety Specialist jobs - AtriCure jobs

We are searching for a Senior Safety Specialist. This is a clinical position. Candidates must be an RN, with a bachelor's degree or the equivalent, with clinical trials experience. Application directions are at the bottom of the posting.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions in cardiac tissue for the treatment of atrial fibrillation, or AF, and systems for the exclusion of the left atrial appendage. Cardiothoracic surgeons are adopting AtriCure’s ablation products for the treatment of AF during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. AtriCure’s Synergy Ablation System is the first and only device approved by the FDA for the treatment of Persistent and Longstanding Persistent forms of Afib in patients undergoing certain open concomitant procedures.

The Senior Safety Specialist is responsible for all safety-related aspects of a clinical trial. The role will monitor ongoing clinical trials by auditing, maintaining, and ensuring the accuracy of a safety tracking system. This position works closely with marketing, research, regulatory affairs, CRAs , and investigators.

Roles and Responsibilities:

  • Provides input into the company’s clinical research strategy and the design of clinical studies from an operational perspective
  • Implements approved clinical trial protocols and operational plans, which are consistent with strategic corporate and assumes primary accountability for the ongoing progress of those plans on assigned studies
  • Ensures the appropriate development of all study documents, including but not limited to: study documents, consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies
  • Oversee the collection, processing, and tracking of serious adverse event reports
  • Coordinate safety-related regulatory reporting to global health authorities
  • Manage the overall process for additional safety-related tasks - (i.e., laboratory and trend review)
  • Provide safety advice to other departments
  • Provide review of interdisciplinary study-specific documents for consistency and compliance
  • Train internal and external contacts on safety-related matters
  • Collect, process, and track serious adverse event (SAE) reports and clinical event documents
  • Generate and track study report narratives
  • Coordinate safety surveillance activities (e.g., lab review, trend analysis)
  • Generate investigator safety letters
  • Assist in preparation of clinical safety documents

Qualifications:

  • RN with a bachelor’s degree or equivalent is required
  • A minimum of one year of clinical experience
  • Prior clinical research experience is preferred
  • Proficient knowledge of Microsoft® Office
  • Experience writing, reviewing and editing protocols and clinical study reports
  • Working knowledge of guidelines and FDA regulations for prospective clinical trials
  • Ability to exercise judgment and determine appropriate action
  • Ability to manage deadlines
  • Ability to work in a fast-paced environment
  • Exceptional verbal and written communication skills

For immediate consideration, please apply using the following link:
http://www.atricure.com/about/open-positions


Indeed - 11 months ago - save job - block