International, rapidly growing CRO is seeking a talented Clinical Research Associate. The new incumbent will be accountable for study site management including site selection, initiation, routine monitoring, close-out and maintenance of study files. CRA also ensures the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.
Our Clients are a full service globally based Contract Research Organisation with in-depth experience of the most challenging therapeutic areas. They are seeking an experienced Clinical Research Associate, to come on board to assist with the monitoring of their growing portfolio of projects.
We are currently hiring for CRA positions in different locations in Poland, variety of Sponsors who are Top 10 Pharmaceutical Companies. Interesting studies, possibilities to adjust to your expectations as per clinical career development.
Providing your application will give you access to recent job openings.
Duties associated with the role include:
- Review approved protocol and ensure qualification, initiation, monitoring and closeout visits for research sites are carried out in full compliance;
- Ensure overall integrity of study and adherence to guidelines, protocol and regulations;
- Complete monitoring reports and follow up letters, including providing the summaries of significant findings, deviations, deficiencies and recommended actions to secure compliance;
- Take an active role in the project team by providing feedback and suggestions for successful completion of the project;
- Coach and mentor less experienced CRAs to assist in their development and training;
Requirements:
- University degree in life sciences/pharmacy/biotechnology;
- At least 1 year of independent monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) according to protocol monitoring guidelines, SOPs, GCP/ICH Guidelines;
- Computer competency;
- Fluent command of English;
- Ability to complete tasks in an accurate and timely manner;
- This is a really exciting opportunity to join a team dedicated to supporting the development of ground-breaking drugs;
We offer:
- A stable contract of employment and a very attractive benefits system; including extra days off, an employee referral system, a beneficial loyalty program, private medical healthcare and a sports card;
- High class professional working equipment;
- Onboarding process to enable you fast takeover of duties;
- International and supportive environment;
- We are proud of our friendly working atmosphere.