Precision for Medicine needs to monitor and manage clinical studies at investigative sites to ensure they are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Requirements
- CRA experience within the CRO or pharmaceutical industry
- Oncology experience is essential
- Study start up activities experience
- Understanding of financial management (for Senior CRAs)
- Knowledge of ICH-GCP and all applicable regulations and standards
- Experience with clinical trial execution and management
- Familiarity with laboratory expertise and advanced data sciences
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
- Identify potential study risks and propose solutions on how to mitigate them
- 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
Other
- 4-year college degree or equivalent experience
- Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline (preferred)
- 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
- Excellent communication and interpersonal skills
- Ability to handle conflict and difficult situations
- Strong problem-solving and analytical skills
