Klinik Araştırma Uzmanı

CO Tıbbi Araştırma Danışmanlık Ltd.Şti.

Sponsor Dedicated Clinical Research Assosiate-CO Research

Job Description:

Clinical Research Associate (CRA) will be responsible for conducting clinical studies, managing & monitoring of study sites in accordance with SOPs, ICH-GCP (International Clinical Harmonization-Good Clinical Practice) and local regulations. CRA will manage multiple projects, support Project Team and report directly to Clinical Project Manager.

Responsibilities

• Conduct pre-study, initiation, monitoring, and closeout visits for research sites;
• Perform source document verification and case report form review;
• Perform regulatory document review;
• Conduct study drug inventory;
• Perform adverse event and serious adverse event reporting and follow-up; and
• Assess patient recruitment and retention.

Qualifications

• University degree in Medical Sciences (Pharmacy, Biology, Chemistry, Genetics, Medicine or a related field)
• Excellent command of written and spoken English,
• Ability to manages Risk Based Monitoring concepts and processes
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Strong project management skills together with teamwork,
• Organised, creative and confident with good communication skills,
• Good time management,
• Excellent presentation, planning and organization skills,
• Exceptional attention to details,
• Ability to travel,
• Broad knowledge of medical terminology and clinical patient management;
• Basic knowledge of drug therapy techniques and clinical research methodologies;
• No military obligation (for male candidates).

Experience

• At least 1 year experience as a CRA and Oncology experience is expected.