Job Listing: Regional CRA

A leading pharmaceutical company is seeking an experienced Regional CRA to join their dynamic team.

Responsibilities:

* Conducts Site Selection Visits to confirm the investigator is qualified and has suitable resources and facilities to properly conduct the study.
* Completes study initiation visits with study staff through training on protocol procedures, drug accountability procedures, reviewing regulatory requirements, and collecting outstanding documents.
* Responsible for training and supervising site personnel on study protocol and procedures throughout the study and continuously assesses site performance, processes and qualifications of staff.
* Responsible for managing site personnel to ensure adequate resources at site to conduct study activities for duration of project. Responsible for tracking enrollment activities to ensure commitments are met. Identifies potential issues, develops contingency plans and works with site to optimize performance.
* Completes monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting in accordance with SOPs.
* Responsible for ensuring applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations. Ensures all information needed for Medical Research report and Regulatory submissions are accurate, appropriately filed, and site is fully prepared for the rigor of a Regulatory Inspection.

Requirements:

* Minimum of 1-2 years of on site monitoring experience.
* Excellent verbal and written communication skills.
* Oncology experience required.

Required Skills for Regional CRA Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.