Senior Clinical Research Associate

pfm medical, inc. Logo

pfm medical, inc.

πŸ“Remote - Italy

Summary

Join Precision for Medicine, a CRO with a focus on cultivating a positive work environment and high CRA retention rates. As a Senior Clinical Research Associate, you will be responsible for monitoring and owning the progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, and regulations. You will coordinate all necessary activities for study setup and monitoring, including identifying investigators, preparing regulatory submissions, and conducting pre-study and initiation visits. You will also have the opportunity to train and mentor junior staff members, interact directly with clients, initiate payments, and participate in proposal activities. This position offers a flexible work arrangement, allowing you to work fully from home. The company values work-life balance and provides reasonable travel requirements, typically involving domestic travel with overnight stays.

Requirements

  • 4-year college degree or equivalent experience
  • Holder of CRA certificate
  • CRA experience within the CRO or pharmaceutical industry; 2+ years for a CRA II and 3+ years for Senior CRAs
  • Oncology 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)
  • Fluency in English and for non-English speaking countries the local language of country where position based

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.)
  • Senior CRAs 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

Preferred Qualifications

  • Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
  • Two+ years of oncology experience
  • Study start up activities experience
  • For Senior CRAs, understanding of financial management

Benefits

This position can be offered fully home based

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