Senior Clinical Research Associate I

Job Description

Advance your career and lead challenging full-service clinical research projects. As a Senior CRA I at PSI you will get hands-on involvement in every aspect of the study.

Greece country-wide, home-based

The scope of responsibilities will include:

• Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
• Site management, general administration of clinical research studies
• Supervision of study set-up, clinical monitoring and site management activities on a country level
• Monitoring trial progress and ensuring that project timelines and patient enrollment schedules are met
• Facilitating site contractual start-up and site budget processes
• Coordination of site regulatory documents collection
• Management of investigator site payments
• Communication point for investigational sites, project teams and support staff
• Back up communication point for vendors and clients
• Delivering onsite training of investigators and staff; in-house project team training
• Preparation and delivering of presentations at Investigator’s Meetings
• Compliance monitoring, participation in quality control activities; review of monitoring reports
• Preparation for and attendance at company’s audits; follow up and resolution of audit findings
• Maintenance of study-specific and corporate tracking systems at site and country level
• Participation in feasibility research

Qualifications

•  College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• At least 3 years of independent on-site monitoring experience in Greece
• Experience in all types of monitoring visits in Phase II and/or III
• Experience in in Oncology, Hematology, Gastroenterology and Infections is a strong advantage
• Full working proficiency in English and Greek
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel