REGIONAL MONITOR

Description:
CRA/Monitor for Cardiolite Pediatric Program - Full Time - must be local to Billerica to work in-house on site recruitment/management activities when not traveling to site visits.

Cardiolite Pediatrics Program Project Description :
Responsibilities will include site recruitment (PSV, reg doc collection, initiation), monitoring and close out for three studies. Looking for one FTE, could be two people. Prefer local person to Billerica, MA so spend some time in house as needed. Experience monitoring in Canada. Cardiovascular and/or nuclear medicine/imaging experience a plus.
REQUIREMENTS
Requirements:
Candidate with a BA, BS, or an MS Degree is Preferred. CRF Review and Verification. ICH Guidelines/FDA Regulations/ Client SOP Knowledge. On Site Monitoring of Investigational Drug Trials. Scientific, Clinical Research Process, and Methodology, and Regulatory Knowledge. Site Selection and Evaluation of Investigators. Verify Compliance and Adequacy of Drug Supplies/Storage. Verify Regulatory Status of Sites/Documents .