Precision for Medicine is looking to solve the business problem of supporting continued growth from clients by hiring experienced Clinical Research Associates (CRAs) in monitoring Oncology, to ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Requirements
- experience in monitoring oncology
- 2+ years CRA experience within the CRO or pharmaceutical industry
- 4+ year of CRA experience within the CRO or pharmaceutical industry to be considered for a Sr. CRA
- fluency in English and for non-English speaking countries the local language of country where position based
- experience with study start up activities
- knowledge of ICH-GCP and applicable regulations and standards
- experience with clinical trial designs and operational expertise
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
- work with 2-3 protocols on average and support Project Managers with trials that are larger in scope
- interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations
- conduct pre-study and initiation visits
Other
- 4-year college degree or equivalent experience
- availability for domestic travel including overnight stays, up to approximately 50-60% travel commitment
- potential international travel may be required for some senior level positions
- calm, thoughtful, and responsive when things don’t go as planned
- well-prepared, whether it be for an investigator meeting, site visit, or project team update
