Candidates should have at least 4 years of clinical trial monitoring experience
The Senior Clinical Research Associate (sCRA) is a member of the clinical development team who is responsible for all aspects of study site monitoring to ensure that the rights and well-being of human subjects are protected; the reported trial data are accurate, complete and verifiable from source documents, and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), relevant study specific documentation, Standard Operating Procedures, ICH GCP Guidelines and applicable regulatory requirements. In doing this, the Senior Clinical Research Associate represents Company and the Client/ Sponsor to site personnel and colleagues with professionalism and integrity.
University degree, preferably in medical or life sciences. Individuals with university degree in biotechnical, technical, bio medicinal, social or humanistic sciences must have nursing education or other relevant healthcare college degree.
Experience and knowledge
Candidates should have at least 4 (four) years of clinical trial monitoring experience;
High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research;
Excellent understanding of clinical trial process;
Experience in Quality Systems and audit/inspection visits;
Fluent in local language and in English, both, written and verbal;
Computer proficiency is mandatory.
Skills and personality
Ability to read, analyze, and interpret common scientific and technical journals.
Excellent verbal and written communication skills;
Very good interpersonal and negotiation skills;
Ability to work with minimal supervision;
Affinity to work effectively and efficiently in a matrix environment;
Excellent numerical skills and reasoning ability;
A current, valid driver’s license would be advantageous (position requires up to 30% of travel).
By joining our fast growing and prosperous Clinical Operations team, you will have a great opportunity for further personal growth and career development. We offer opportunity to work on the international projects and to be member of international clinical research teams, competitive compensation and benefits package, a lot of training opportunities and flexible working hours.
We are currently opening a new office in Sofia and are looking for ambitious individuals to join our Optimapharm team in Bulgaria. We look forward to receiving your CV in English.