Senior Clinical Research Associate

December 4

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PSI CRO AG

Number One Patient Enrollment CRO • Clinical Research • Clinical Trials • Oncology • Hematology

Description

• Home-based position in Colombia • Only CV's in English will be considered • We are looking for an experienced CRA ready to train and coordinate junior CRAs on site. • Here you will have the opportunity to develop yourself as a trainer, mentor and leader. • We are committed to develop our employees in their careers by providing tailored courses and mentoring. • Responsibilities will include: Training, mentoring and supervising study level responsibilities for Jr. CRAs • Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits • Delivering training of investigators, site staff and project teams • Work with complex studies • Perform CRF review, source document verification and query resolution • Be responsible for site communication and management • Be involved in site identification process • Contact for clinical investigators, vendors and support services in regard to study progress • Participate in feasibility research • Preparation and delivering of presentations at Investigator’s Meetings • Preparation for and attendance at company’s audits; resolution of audit findings • Support to Regulatory Affairs in procurement of site regulatory documents • Maintenance of study-specific automated tracking systems

Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience • Full working proficiency in Spanish and English • Independent on-site monitoring experience in Colombia • Experience in all types of monitoring visits in Phase II and/or III • Availability to travel • Experience in Oncology or Infectious Diseases is a plus • Proficiency in MS Office applications • Ability to plan and work in a dynamic team environment • Communication, collaboration, and problem-solving skills

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