Senior Clinical Research Associate

Job Description

3-6 years of experience with CRA tasks such as remote monitoring, SOP creation, site selection setup, setup execution, protocol development; medical device experience is preferred.

• Preferred if the candidate has at least one CRA job experience from the sponsor side.
• If the candidate has only CRO-based experience, then being coachable is required.
• Many CRO-focused candidates have a narrowed experience with repetitive core CRA tasks directed by a manager; this is a common CRO model with team resources assigned to discrete functional tasks.
• Our model expects Sr/CRAs to be flexible, able to anticipate, pivot, independently lead tasks and lead others, and to wear multiple hats (using knowledge of regulations, data management, document creation, etc.) throughout all phases of the study. Candidates should be able to troubleshoot during study execution and perform with little to medium oversight.
• Focusing mostly on-site data monitoring is a flag; covering all visit types evenly is needed.
• Experience in creating (not just reviewing) clinical documents such as training materials for SIVs, protocols, CRFs, ICFs, and brochures.
• Experience participating in Data Management activities like UAT (user acceptance testing) and Study Reviews can distinguish a preferred candidate.
• Experience/knowledge with US sites and US regulations is definitely considered as most of our studies need this.
• Having device and/or IVD experience.