Job Location: Berlin , Germany
Experience: 2 To 15 (years)
To support the continuous and strong growth in number of projects and to strengthen the Clinical team OPTIMAPHARM is looking for a highly motivated and experienced individual for the position of Clinical Research Associate. RESPONSIBILITIES The Clinical Research Associate (CRA) 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 Clinical Research Associate represents Company and the Client/ Sponsor to site personnel and colleagues with professionalism and integrity. By joining our fast growing and prosperous team, you will have a great opportunity for further personal growth and career development. We offer the opportunity to work on international projects and to be a member of international clinical research teams, a competitive salary, lots of training opportunities and flexible working hours. Please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for further selection process.
EDUCATION 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 2-3 years of individual clinical trial monitoring experience, experience in oncology studies is an advantage • 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)
Established in 2006, Optimapharm is a full-service Contract Research Organization that provides tailored solutions for our clients, and has a high-level of expertise in managing trials across Europe. With unrivalled access to patients in the emerging markets of Eastern and South Eastern Europe, and with strong presence in Western Europe, our operational excellence and customer-focused approach has resulted in our achieving a 95% repeat business level. With 14 offices geographically and strategically located in Europe, plus a network of preferred partners in the US and Israel, Optimapharm is highly qualified to manage trials across Europe, the US and Israel, supporting Biotech, Pharma and Medical Device companies to reach both small and large patient populations in several indications, whilst achieving competitive start-up timelines at competitive prices.
