You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Senior CRAs handle appropriately sized clinical trials and support Project Managers with trials that are larger in scope.
You will also have the opportunity to train and mentor junior staff members.
You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.
Requirements
University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional.
3.5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Significant site management experience or equivalent experience in clinical research
Oncology monitoring experience
Tech Stack
Google Cloud Platform
Benefits
Excellent communication and organizational skills are essential. A team player
Evidence of a client focused approach
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed