Precision for Medicine, Oncology and Rare Disease is looking for a Clinical Research Associate II/ Senior Clinical Research Associate to manage and perform monitoring visits in sites in Spain, ensuring clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Requirements
- 3+ years of CRA experience within the CRO or pharmaceutical industry;
- Experience in managing the sites in Spain
- Oncology and radiopharmaceutical or biopharma experience
- Start up activities experience
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.).
- Clinical Research Associate II/ Senior Clinical Research Associate II 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.
