·         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.

Qualifications:

·         Preferred if they have at least one CRA job experience from the sponsor side

·         If they have only CRO-based experience, then being coachable is required

·         We have found that many CRO-focused candidates have a more narrowed experience with repetitive core CRA tasks directed by a manager (we understand this is a common CRO model with team resources assigned to discrete functional tasks).

·         Our model has more of an expectation that Sr/CRAs will be flexible and able to anticipate, pivot, independently lead tasks and lead others (so we screen for people who can: wear multiple hats (using knowledge of regulations, data management, document creation etc.) throughout all phases of the study, be able to troubleshoot during study execution and perform with little to medium oversight)

·         If they have focused mostly on-site data monitoring, this is a flag; covering all visit types ~evenly is needed.

·         We look for experience in creating (not just reviewing) clinical documents such as training materials for SIVs, protocols, CRFs, ICFs, brochures.

·         Experience participating in Data Management activities like UAT (user acceptance testing) and Study Reviews can serve to 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.