Precision for Medicine is looking to solve the problem of conducting clinical studies in the field of oncology, specifically in the area of precision medicine, by hiring a Clinical Research Associate (CRA) to monitor and manage clinical studies at investigative sites.
Requirements
- At least 2 years CRA experience within the CRO or pharmaceutical industry
- Oncology experience, early phase experience desirable although not essential
- Fluency in English
- Knowledge of ICH-GCP and applicable regulations and standards
- Experience with clinical trial designs and operational expertise
- Familiarity with biomarker and data analytics solutions
- Experience with targeted, adaptive clinical trials
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.)
- Identify potential study risks and propose solutions on how to mitigate them
- Take responsibility in the quality and outcomes of your work
- Conduct pre-study and initiation visits
- Help prepare regulatory submissions
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
- Ability to work in a home-based setting
- Strong communication and conflict resolution skills
