Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation
Submission of protocol, consent documents for ethics / IRB approval and assist in preparing regulatory submissions as requested
Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness
Dependent on level of experience you may assist in training and mentoring less expert CRA's and / or lead CRA's working on international projects
What you need
3 years+ of monitoring experience in phase I-III trials as a CRA
Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
You will possess excellent written and verbal communication in English
Ability to produce accurate work to tight deadlines within a pressurized environment
You will be asked to travel at least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license
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