To support the continuous and strong growth in the 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 (m/f) in Poland.
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.
The new person might be involved to support regulatory activities and be in contact with regulatory authority and ethics committees.
In doing this, the 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 degrees 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 years of individual clinical trial monitoring experience, experience in neurology and oncology studies and medical devices is an advantage
- High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
- Experience in regulatory and ethics committee submissions and communication is an advantage
- Excellent understanding of the clinical trial process
- Experience in Quality Systems and audit/inspection visits
- Fluent in local language and 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, pro-active
- 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 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 the further selection process.