Ogłoszenie numer: 2492420, from 2019-06-11
OPTIMAPHARM is a full service CRO (Contract Research Organization), that was established in 2005 and has a high expertise of managing trials in emerging markets, providing tailor made solutions to its clients with 95% of repeated business. Having offices in Western, Central and Eastern Europe, and covering a population of 150 million people, having a network of preferred partners, OPTIMAPHARM is 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. OPTIMAPHARM is a service company with confidence, quality, expertise, integrity, intelligence and flexibility as guiding principles in development of innovative life science products. OPTIMAPHARM is a joint stock company owned by the management. OPTIMAPHARM's mission is to provide the flexible, high standard and client focused services to pharmaceutical, biotechnology and medical devices companies in order to develop better medicines for people. We have on board the most experienced team of clinical research professionals in the region.
Clinical Research Associate
Location: dolnośląskie
Reference No.: 23052019
Job description
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 2-3 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)
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.
Please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for further selection process.