Lead CRA

Lead CRA:

 

Company Profile-

ClinAssure, Inc is a Contract Research Organization (CRO) which provides clinical research services and related support to pharmaceutical companies located in the western region of the United States.  We are located in Irvine, California and are in the process of recruiting and interviewing potential candidates to fill the position of Lead CRA.

 

Position Description-

Oversee functional management of sites and CRAs, report to Study Manager. Primary job functions and responsibilities:Oversight of site selection/initiation/monitoring visits/close-outsEnsure compliance with ICH/GCP guidelines and protocolPrepare/present at Investigator MeetingsOrganize/facilitate CRA meetingsDevelopment/review of project documentationConduct training and performance reviews of CRAs30-40% travelReview/consolidate protocol violations/deviations into master tracking log

 

Requirements-BS degree in scientific discipline7-9 years relevant clinical research experienceKnowledge of FDA/ICH GCP guidelinesExperience managing/monitoring investigative clinical trial sitesStrong organizational/time-management/multi-tasking skillsExcellent verbal and written communication skills

 

Compensation and Benefits-

Benefits include:Medical, dental, vision insurance paid 100% by the company 12 paid vacation days 9 paid holidays Paid sick days 401(k) plan with company matching and accelerated vesting schedule Flexible Spending Account (FSA) plan Tuition reimbursement program And other benefits.