Senior Clinical Research Associate
Advanced Clinical - Chicago, IL

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Job Number: 413518

Senior Clinical Research Associate

Senior Clinical Research Associate (MN or Home-based)
  • 3+ years of in-house Clinical Research Associate experience, and not just Monitoring experience.
  • This position is necessary to help in the study startup of the Drug Coated Balloon (DCB) Global study.
  • Duties will include Site Management, Vendor Management and Project Management responsibilities (under a Global Project Manager) for Latin America; specifically Colombia.
  • The Senior CRA will work with the Clinical Research Specialist to satisfy applicable regulatory standards and company requirements for worldwide Clinical Studies.
  • This position bridges the responsibilities of the Clinical Research Coordinator and the Clinical Research Specialist, and focuses on study management activities, oversight of CRO's, etc.
  • Assists with successful conduct of assigned studies consistent with R&D and Marketing plans. This includes interfacing with representatives from key functional groups including Field Clinical Operations, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and European Clinical Groups.
  • Assists in preparation of study materials and training of investigators, center staff and ev3 field staff.
  • Writes the monitoring plan
  • Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents.
  • Reviews clinical data/information and oversees data correction. Assists clinical research specialists in providing interim and final reports and presentations.
  • Provides input to study budgets and project plans.
  • Assists clinical research specialists by providing sections of Investigational Plan or protocol as needed.
  • Assists Clinical Research Specialist in writing sections of the PMA Clinical Reports.
  • Takes initiative to oversee activities of Contract Research Organizations (CRO's).
  • Reviews and verifies adequacy of center activation documentation.
  • Position may require up to 35% travel. May include trips within the US, Europe, or Latin America
Qualifications & Skills

Does not have to be a local candidate to MN Office. Can work remotely from another state *

Four year degree required *

3-5 years of experience as an in-house Clinical Research Associate required (NOT JUST MONITORING) *

Project Management skills required *

Medical Device experience required (Combination product experience a plus) *

CRO management experience required *

Latin America experience required (Colombia specifically a plus) *

Spanish speaking a plus *

Ability to travel up to 35% - may include trips within the US, Europe, or Latin America *

High attention to detail and accuracy. *

Advanced written and oral communications skills. *

Able to manage multiple tasks. *

Proficient knowledge of medical terminology. *

Expertise with GCPs and regulatory compliance guidelines for clinical trials. *

Good problem-solving skills. *

Knowledge of clinical and outcomes research study design.

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