Krka d.d. is one of the leading generic pharmaceutical companies in the world. We have been successfully implementing our strategies and pursuing our mission and vision for more than 65 years. Krka’s basic line of business is the production and sale of prescription pharmaceuticals, non-prescription products and animal health products. The company’s activities are supplemented by health resort and tourist services. Our products are sold in over 70 countries. For more information visit http://www.krka.biz/en/."
CLINICAL RESEARCH COORDINATOR
Krka is one of the leading generic pharmaceutical companies in the world. We have now been successfully implementing our strategies and pursuing our mission and vision for more than 60 years. Krka’s basic line of business is the production and sale of prescription pharmaceuticals, non-prescription products and animal health products. Krka´s medicines are trusted and clinically proven. We have been gaining evidences for almost 40 years. Our products are sold in over 70 countries.
We invite you to join our team where partner relationships are based on mutual trust and respect and offer dynamic work on challenging and motivating projects.
For our affiliate company KRKA ČR, s. r. o., based in Prague we are searching for Clinical Research Coordinator.
- Participate in the preparation, initiation, conducting, and managing different types of clinical researches, e.g. non-interventional studies, epidemiological studies, epidemiological researches, interventional clinical studies, and other
- Prepare study-related documentation for submission to the Ethics committees (ECs) and Regulatory authorities (RAs) in cooperation with the HQ clinical research team
- Ensure that clinical studies and related activities are performed in accordance with GCP, local laws and regulations, Krka’s corporate Code, policies, and procedures
- Management of the day-to-day activities related to the study, e.g. study site management, proactive identification and timely resolution of study-related issues, communication with site personnel, RA, EC, and study vendors, etc.
- Ensure accurate and timely reporting of serious adverse events their follow-up and perform other pharmacovigilance activities
- Ensure that study documentation is available, accurate, and ready for inspection
- Cooperate in data management to ensure robust quality of the collected study data as per requirements from various regulatory agencies
- Deputy person for pharmacovigilance activities
- Authorised person for quality system management
The ideal candidate will have:
- University degree in one of the following fields: medicine, pharmacy, veterinary or other life sciences with proven knowledge
- Experiences with work as CRA at least 1 year or equivalent combination of education, training, and/or experience
- Knowledge of international guidelines ICH-GCP, local laws and regulations
- Experience in Pharmacovigilance
- Fluent Czech and fluent English (written and spoken form)
- Excellent communication, both written and verbal, and interpersonal skills
- Excellent attention to detail, good administrative and IT skills (relevant database systems)
- Driving license
What we offer:
- Interesting and dynamic work in a professional team in an international company
- Be a part of complete oversight into Krka´s medicines and the environment in which they are used
- Possibility of professional growth and training program
- Competitive remuneration package
Informace o pozici
- KRKA ČR, s.r.o.
- Sokolovská 192/79, Praha – Karlín
- Required education: University
- Required languages: English (Proficient)
- Benefits: Cell phone, Notebook, Meal tickets / catering allowance, Holidays 5 weeks
- Listed in: Research and development, Health and social care, Pharmaceutical, Research worker, researcher, Veterinary surgeon, General practitioner, Clinical studies assistant, Clinical Studies Monitor, Regulatory Manager
- Employment form
- Employment form: Full-time work
- Contract duration
- Contract duration: Limited (temporary)
- Employment contract
- Employment contract: employment contract
- Employer type: Employer