Senior Clinical Research Associate
연봉 Negotiable based on experience
컨설턴트 Rachel Park
채용 공고일 2018년 10월 24일 (수)26 Euljiro 5 gil Jung-gu Seoul 04539 Robert Walters
A European research company is looking for a new Senior Clinical Research Associate. This position will be responsible for managing and monitory clinical trials for the company. This is a great opportunity to advance your career with a global company.
- Support study protocol design and review and monitor clinical trials to ensure compliance to Good Clinical Practice, ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements, etc.
- Conduct site management to ensure adherence to protocol, verify source data, and assess case report forms
- Develop, edit, and compile clinical trial and research documentation such as case report forms, informed consent forms, study specific handbooks, guidelines and checklists
- Conduct pre-study initiation, interim monitoring and close out visits
- Carry out drug formulation administration procedures and documentation and ensure adequate drug shipments and drug accountability
- Serve as the point of contact with the medical monitor, principal investigator, clinical operations staff and sponsor representatives and participate in required meetings
- Support management with ad-hoc tasks as needed
- Bachelor’s degree equivalent or higher in medicine, biology, pharmacology, nursing, or related field
- Detailed understanding of the drug development process with work experience at a hospital, medical or research centre, contract research organisation or pharmaceutical company as research associate
- Experience with ICH-GCP and relevant local regulatory requirements during clinical trials
- Ability to support the development of clinical trial documents and materials, independently perform pre-study initiation, and interim monitoring and close out visits
- Ability and willingness to travel
- Fluent level English
About the Company:
A multinational contract research organization (CRO) that provides a range of clinical services to the pharmaceutical, biotech, and medical fields. Headquartered in Europe, the company has a presence in over 50 countries around the world.