Clinical Research Associate (m/f)
The mission of the CRA is to ensure that the conduct of clinical trial at selected investigational sites is according to the currently approved protocol/amendments, ICH-Good Clinical Practice guidelines, the Standard Operating Procedures (SOPs) and the applicable laws and regulations.
Client Details
Our Client is a dynamically growing Contract Research Organization with over 200 employees operating in 16 countries in Europe. Company has nearly 20 years of expertise on the market and provides services to more than 250 clients worldwide. Our Client is passionate about talented people who dream big, who embody positive energy and effective communication, who drive initiatives and who thrive on challenges. Poland remains one of the key country in CEE region and due to further development of the business, we are looking for an independent Clinical Research Associate (CRA) to join an international, matrix structure.
Description
- acting as a local expert for delivery of high quality feasibility services
- ensuring that the subject's rights are respected and that all collected clinical trial data are accurate, complete and verifiable from source documents for both interventional and non-interventional studies
- planning and controlling of a clinical trial with respect to timelines, milestones, recruitment and resources, meeting and exceeding client's expectations, in collaboration with Project Manager
- adequate monitoring of the clinical trial conduct at the investigational sites
- being a principal point of contact with the company group and ensuring relationship with the sponsor develops to its full satisfaction by minimizing potential issues/escalations
- acting as the main link between company and the investigator: explaining the purposes, the set-up and the procedures
- training and assisting the investigators in the conduct of clinical trials (Informed consent process, drug accountability)
- maximization of the profitability of his/her project
Profile
- Strong Scientific background as Pharmacist, Medical Doctor or biology related diploma (BS or MS), Health Care Professional (nurse, etc.) is required
- Proven track record in the clinical research area, including least 3 years' experience in monitoring
- Profound understanding of international and local regulatory requirements
- Self-starter with proactive and hands-on approach, requiring little supervision
- Strong in multi-tasking, prioritizing, keeping deadlines and operating promptly and efficiently
- Capable of working well under pressure to meet deadline coupled with a good understanding of working as part of a team in a demanding multinational environment
- Excellent communication and organizational skills
- Fluent English both written and spoken is a must
- Project management skills
- High level of computer literacy is expected
Job Offer
- Opportunity to work independently, take on initiatives and responsibility
- Being a part of dynamically growing organization with significant potential in CEE
- Attractive compensation package and international career prospects
Location: Poland
Contract type: Na czas nieokreślony
About Michael Page
Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers.
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