Precision for Medicine is looking to solve the problem of conducting clinical studies in oncology, specifically in the area of precision medicine, by hiring a Senior Clinical Research Associate to monitor and own the progress of 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
- Holder of CRA certificate
- Fluency in English and for non-English speaking countries the local language of country where position based
- Study start up activities experience
- Understanding of financial management
- Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
Responsibilities
- Monitor and own the progress of clinical studies at investigative sites
- Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards
- 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.)
- Handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope
- Train and mentor junior staff members
- Interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations
- Identify potential study risks and propose solutions on how to mitigate them
Other
- 4-year college degree or equivalent experience
- Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
- 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 take responsibility in the quality and outcomes of your work
