Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
Submitting protocol, consent documents for ethics / IRB approval, as well as preparing regulatory submissions
Balancing sponsor generated queries
Taking responsibility for study cost efficiency
Preparation and review of study documentation and feasibility studies for new proposals
Potential to assist in training and mentoring fellow CRAs
You will need :
18 months+ of monitoring experience in phase I-III trials as a CRA
College degree in medicine, science, or equivalent
Previous monitoring experience in medium-sized studies, including study start-up and close-out
Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
Excellent written and verbal communication
Ability to work to tight deadlines
Availability to travel least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license
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