Clinical Research Associate - Medical Device

BeneChill, Inc. is an early stage medical device company developing non-invasive cooling technology for the treatment of cerebral ischemia. 

Summary

The Clinical Research Associate will aid in the development, implementation and management of clinical trials.

Responsibilities

Basic responsibilities include the following. Other duties may be assigned.Provides internal support in the development of clinical trial materials, including case report forms, informed consent materials, protocol amendments, etc.Provides internal support for site recruitment, site qualification, and site initiationConducts data monitoring visits for the purpose of verification of clinical source data and ensure regulatory compliance of investigators/sitesProvides external support with study/site management including: qualification visits, monitoring visits, close-out visits, reconciliation of site and in-house regulatory documentation, clinical review of study documents, and device accountability.Communicates with Investigators and various members of the site?s investigator team to ensure proper study conduct and adherence to regulations.May require up to 30% travel

Qualifications 

The successful candidate should have the following qualifications:Working knowledge of Federal and International regulations governing clinical trialsExpertise with GCPs and regulatory compliance guidelines for clinical trialsProficient in MS Office applications and the InternetWell organized and efficientAble to manage multiple tasksAdvanced written and oral communication skillsAbility to review and edit technical and clinical materialsKnowledge of clinical and outcomes research study designStart-up experience a plus

Education and Experience

A 4-year Bachelor degree with at least 2 years relevant experience in field clinical trials or product evaluations at the site level, with emphasis on regulated medical devices is desired.  Six years relevant experience will be considered of in lieu of a 4-year degree.