Are you a team player interested in clinical trial site management activities? Does dealing with people from different backgrounds excite you? Are you a highly adaptable and organized person who thrives in a fast-paced, dynamic work environment? If yes, then you are the Clinical Research Associate (CRA) we are looking for! Join us and be part of a patient-centric global pharmaceutical company whose aim is to change patients’ lives. Apply now.
In Novo Nordisk Bulgaria, the position of Clinical Research Associate provides you the opportunity to work in a high performing team while creating values for patients. You will be the primary point of contact between site staff and Novo Nordisk. You will be responsible for monitoring of the study at sites in compliance with local regulations, NN SOPs, protocol requirements and Good clinical practice to ensure data quality and study subject protection, as well as for recruitment at site level. In this role, you will deliver results that have a direct impact on the successful completion of the clinical program.
Your main responsibilities will be
- Communicate with sites for ensuring adequate enrolment rate. Train and guide the site staff in the protocol and trial procedures.
- Maintain and update study related documentation from CRA’s area responsibility. Maintain clinical trials systems up to date.
- Prepare and submit Monitoring Visit Reports within defined timelines. Perform clinical on-site monitoring activities (source data verification and review, drug accountability, data collection etc.).
- Identify potential risks and proactively take action to prevent or mitigate. Support audit and inspections at sites as applicable.
- Participate in internal working groups, initiatives and represent Novo Nordisk in external working groups and at conferences.
- You hold min. Bachelor´s degree – pharmaceutical/medical or life science will be an advantage;
- Experience in independent monitoring from a similar position in the pharmaceutical industry or a Clinical Research Organization (CRO) is an advantage;
- Knowledge of GCP and local laws and regulations for clinical trials is an advantage;
- Computer literacy: MS Office, experience with SOP;
- Excellent verbal and written communication skills in English and Bulgarian;
- Willing and able to travel ( up to 70% of a time), you hold valid driving license B, traveling in whole Bulgaria will be required;
- Quick problem-solving capability and ability to work in stressful situations, and good analytical skills.
On a personal level, you are good at planning, coordinating & prioritizing activities in order to ensure optimal use of resources in the department, as well as good negotiation, communication & collaboration skills. You are able to relate to people in a diverse & international environment, to handle numerous tasks simultaneously. You act as an ambassador for NN values.
The Bulgarian affiliate is a fast growing and dynamic organization aiming to cement Novo Nordisk’s position on the market. You will also find a highly motivated and dedicated team, unique company culture as well as possibility to learn and develop. We are launching new products, making them more accessible to patients, and we are also aligned with our own long-term commitments through Changing Diabetes® and Changing Obesity®.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here – to ensure that people can lead a life independent of chronic disease.