Precision for Medicine is looking to solve the business and technical problem of improving the speed, cost, and success rate of bringing life-changing therapies to patients by integrating clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences. Specifically, they are seeking Clinical Research Associates II in The Netherlands and Belgium to manage and monitor clinical studies at investigative sites.
Requirements
- CRA experience within the CRO or pharmaceutical industry; 2+ years for a CRA II and 3+ years for Senior CRAs
- Oncology experience is essential.
- Two+ years of oncology experience
- Study start up activities experience
- For Senior CRAs, understanding of financial management
Responsibilities
- 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.
Other
- You are calm, thoughtful, and responsive when things don’t go as planned.
- You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
- You find quick and creative ways of overcoming difficulties.
- You have an impeccable eye for detail.
- You identify potential study risks and propose solutions on how to mitigate them.
