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!
- 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)