Sr CRA – Medical Device – FILLED

The Wellington Group has been engaged to find an experienced Senior Clinical Research Associate with a strong medical device or cardiovascular therapy background. This is a great opportunity to work for one of RTPs leading medical device companies with a focus on current and future technologies.

The ideal professional for this role has worked on the sponsor side of clinical research trials with int’l (EU) trials to include site start-up, audits and close outs. Experience with Phase I and operational details is a strong plus for our client. Responsible for facilitating the management of one or more third party Clinical Research Organizations (CRO). Excellent career opportunity, offering a great benefits, salary, bonus and stock options program!

Responsibilities include:

  • Review and analyze data reports for content and assimilate comments to internal team and/or vendor
  • Prepares reports/summaries of various components of trial activity
  • Designs, plans, develops, and monitors all phases of clinical trials
  • Monitors clinical study sites in accordance with FDA guidelines and regulations
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
  • Provides oversight and direction to CROs and laboratories.  May perform audits of CROs and labs performing contracted services.
  • Site management of clinical study sites including, site training, protocol adherence, general communications and updates
  • Performs pre-study evaluation, site initiation, routine monitoring and close out visits to ensure compliance with the study protocol
  • Develops trip reports with completeness and accuracy
  • Assists with writing, editing, amending, reviewing clinical trial documents, including protocols, sample ICFs or operations manuals (e.g. monitoring plans, CRF completion guidelines, etc.)

The qualified candidate will have:

  • Bachelor’s Degree or equivalent, graduate degree preferred
  • Minimum of eight years of clinical research experience, preference to medical devices, combination products or invasive medical technologies
  • Strong knowledge of ICH – GCPs
  • Experience with both US and EU trials is ideal, the more international expertise the better
  • Demonstrated attention to details and MS Office and computer / internet use
  • Able to travel to sites and vendors as needed

Industry: Medical Device, Cardiovascular, Combination Products, Clinical Research, CRA


Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( ) +1 910-338-2795

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