Academy CRA - USA in München bei Linical Europe

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 more than 700 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 American arm is headquartered in Florida. Its European Headquarters are located in Frankfurt, Germany, with a substantial presence in Paris and Madrid also. Its geographic footprint facilitates a significant presence in North America, the leading Western European markets as well as Asia, combined with well-established affiliate operations in key emerging markets in Central- and Eastern Europe.

Role summary:

The Academy CRA will be trained and mentored by our amazing American team across various activities within Clinical Operations. You will be involved in all relevant aspects of clinical monitoring duties in order to learn from your peers.

The program:

As an Academy CRA, you will receive extensive and incredibly enriching knowledge which will allow you to become a fully- fledged field- based Clinical Research Associate (CRA I). The initial training period lasts 7 weeks.

The Academy CRA program will allow you to learn about conducting routine monitoring activities, establishing and maintaining direct contact with sponsors, TMF, ISF, monitoring plans, ICH- GCP, feasibility, start- up, among others. This is a varied and exciting role, with travel involved for co- monitoring visits.

Main duties:

• Participates in Investigators selection/ feasibility

• Supports and conducts site qualification visits, site initiation visits, routine monitoring visits, as well as site close- out visits

• Supports with feasibilities and start- up activities

• Reviews Trial Master File (TMF)

• Perform co- monitoring visits accompanied with experienced CRAs

• Performs ad- hoc clinical operations duties as required

Education & Experience required:

• University degree (BSc or master’s level) within a scientific or life sciences background
• A Clinical Research Coordinator (or clinical trial site manager) background is preferred
• Knowledge or familiarity with EDC and CTMS systems
• Familiar with MS Office tools
• Fluency in English

Other skills:

• A desire to learn and develop a career within the CRO/ pharmaceutical industry
• A sociable and communicative predisposition
• A passion about clinical trials and making a difference in patient’s lives
• Eagerness to travel in order to perform site monitoring visits

Linical is an equal opportunity employer:

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.