CAPS Medical, a clinical stage medical device company, has developed a highly selective and minimally invasive Non-thermal Atmospheric Plasma (NTAP) device able to painlessly treat a wide range of solid tumors without impacting surrounding tissue. Working at CAPS Medical will enable you to grow your career and join a team of talented people, committed to making a difference in the way cancer is treated.
CAPS medical, is seeking a talented Clinical Research Associate with a focus on research and development of complex multidisciplinary devices, to join our growing team and participate in the development of Non Thermal Plasma technology, with role growth opportunities. In this role you will be a part of a clinical research team and take part in development and execution of the company’s clinical strategy and goals and execution of clinical studies.
· Conduct visits for research sites
· Overseeing the study site staff to assess protocol compliance and appropriate data collection
· Training of site personnel on protocol requirements, proper source documentation, and case report form completion
· Reviewing source data and case report forms for accuracy, completeness, and integrity of the data
· Visit report writing and site correspondence
· Managing and maintaining the Trial Master File
· Support submissions to local ethic committee and to the Ministry of Health
· Take part in development of new clinical applications and Treatment's protocol establishment
· Supporting document control and QA activities
· Management of sub-contractors
· BSc / MSc in life sciences or related field.
· CRA and GCP qualification and certifications -Must
· At least 4 years’ experience as a Clinical Research Associate, preferably in CRO -Must
· At least 2 years of hands on experience in monitoring the medical device studies.
· A working knowledge of applicable and regulations standards, for a conduct of clinical study- Must
· Experience in working in compliance with QualityManagement System.
· High interpersonal skills
· Excellent teamwork skills
· Fluent English
· Must have a valid driver's license and reliabletransportation
To apply, please submit your CV to: