Full ownership of investigator sites for assigned studies with responsibility for the successful management of the site right through to close-out.
Planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan.
Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
Preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues.
Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.
You will be operating as a key part of a global study team and plays a fundamental role in our clients’ drug development processes.
Qualification & Experience
4+ years of Onsite monitoring experience in phase I-III trials as a CRA
2+ years of Global project experience in Oncology studies.
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