Ogłoszenie numer: 2222942, from 2019-01-01
Established in 2006, OPTIMAPHARM is a full service CRO, that provides tailored solution and has a high-level expertise in managing trials across Europe, with an unrivalled access to patients in the emerging market of Eastern and South Eastern Europe. Our operational excellence and customer-focused approach has led to us achieving a 95% repeat business level.
Having offices in Western, Central and Eastern Europe, as well as having a network of preferred partners, OPTIMAPHARM is well qualified to manage trials in the US and Europe, supporting both the Biotech and Pharma companies in reaching large patient populations in various indications whilst achieving competitive start-up timelines at competitive prices.
Clinical Research Associate (m/f)
Location: podlaskie
Reference No.: 1412
Job description
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.
Requirements
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 (two) years of individual 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)
We offer
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.
