Clinical Research Associate

1 day ago

Prague, Hlavní město Praha, Czech Republic Envista Holdings Corporation Full time


Job Description:

Clinical Research Associate plans, implements and manages clinical trials and influences study design and interprets results. Defines clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) for use in clinical trials operations primarily in EU for Kerr Dental products.

Job Requirements:

  • The Clinical Research Associate is responsible for supporting the clinical research activities and clinical evaluations managed by Kerr Clinical Affairs.
  • The primary focus will be coordination, collection, and review of pre-clinical, clinical, and post-market clinical data for medical devices under evaluation.
  • Review/audit CRF's of subjects charts and clinical research data as needed and provides administrative support to the ongoing studies.
  • Supports and/or coordinates preparation of Clinical Evaluations and writing/updating Clinical Evaluation Plans (CEPs)/ Reports (CERs), Post Market Surveillance Plans /Post Market Clinical Follow-up Plans and Reports, Summaries of Safety and Clinical Performance and processes in compliance with EU MDR.
  • Participate in post-market surveillance (PMS) activities as needed (e.g. customer surveys, systematic literature alerts and systematic reviews and preparation of summaries or formal reports for product teams or regulatory agencies.
  • Work closely with the Regulatory team(s) on document strategies. Implement activities related to the preparation of and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents.
  • Able to recognize potential scheduling and resource conflicts for projects across the dental area/product assignments and provide recommendations to resolve the issue.
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. 
  • Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).
  • Experience and skill performing comprehensive literature searches (PubMed, Google Scholar, EMBASE, etc.), review and interpret the literature.

Requirements:

  • Experience in relations to clinical process
  • Education in natural sciences
  • Dental background is a plus

This Job is also suitable for persons with disabilities; attendance required – disabled-accessible building.

#LI-PG1

Operating Company:

Kerr

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

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