CRA II or Sr CRA The Netherlands (all genders)
- Experience Level
- Experienced (non-manager)
Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central- and Eastern Europe.
We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS, based on experience and expertise
CRA Job Scope:
The CRA will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct.
The CRA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
The CRA will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
The CRA will have to anticipate, recognize and resolve issues in the served study sites.
Description of the tasks / routine work:
· Review and/or input to study protocol, CRF, CRF Completion Guideline, Patient Information and Informed Consent Form and validation tools etc.
· Assists in the submission to the Independent Ethics Committees (central and local) and to Competent / Regulatory Authorities
· Assists in developing of Investigator and Institution contracts, negotiates budgets and arranges site payments
· Participates to Investigators selection/feasibility: e.g. phone contacts, questionnaire in the appropriate country
· Conduct of site qualification visits (pre-study visits)
· Conduct of site initiation- and site close out visits
Conduct of regular monitoring visits: check of accuracy of study procedures, source data/document
As an ideal candidate you should have the following profile:
• university degree in sciences or related fields; and experience and knowledge of clinical trials and regulations,
• Advanced English
• at least 1.5 year experience in Clinical Monitoring in a pharmaceutical company or a CRO.
• sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements,
• strong team player combining communication and organizational skills,
• Travel availability
At Linical, we embrace the opportunities and possibilities that are held by diversity, equal opportunity and inclusion. We value bringing together individuals from diverse backgrounds regardless of race, disability, ethnicity, gender, sexual orientation or any other legally protected characteristic. Linical will consider all candidates that match with the requirements of the position, promoting diversity and equal opportunity for all.