Cra Ii

**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 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

**Role summary**:
The CRA II/ Senior CRA is assigned to clinical operation activities and shall guarantee adequacy, reliability and quality of the data collected from sites, participating in quality control processes. The Senior CRA ensures the study is conducted in compliance with the approved protocol, according to ICH GCP, SOPs and all relevant regulatory requirements in Germany_._

This is a varied and exciting role, where the CRA performs a variety of tasks (not just site monitoring). This suits a CRA with at least 2 years of experience, who wishes to be well
- rounded and perform a lower number of visits. Senior CRAs are also encourage to apply

Fluency in German is essential.

**Main duties**:

- Reviews and provide input to study protocol, CRF and validation tools
- Prepares and review any kind of study documents; Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form etc
- Prepares the submission to the Ethics Committees and when applicable to Regulatory Authorities
- Assists in developing of Clinical Trial Agreements and budget template, negotiates budgets with sites and arranges site payments
- Participates to Investigators selection/feasibility in Sweden, Denmark, and Norway, followed by site qualification visits (pre-study visits)
- Participates in investigators meetings and assists in the preparation of these meetings
- Conducts site initiation, close out, and regular on-site monitoring visits: check accuracy of study procedures, source data/document verification to ensure protocol compliance and that the clinical data are complete, logical and accurate.
- Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to
- Maintains close contact with the investigators, the centre study coordinators/nurses the pharmacist and other involved parties
- Reviews of Trial Master File (TMF) to ensure all documents are in order, accurate, complete, up-to-date and ready for any study inspections/audits
- Provides mentoring to new team members and junior CRAs in Europe

**Education & main skills required**:

- University degree (BSc or Masters level) within a scientific or life sciences background
- At least 2 years of experience as CRA in a CRO or Pharmaceutical company
- Familiar with the principles of ICH GCP, SOPs as well as any applicable regulatory requirements and legislation
- Familiar with MS Office tools
- Fluent in German
- Advanced English

**Linical offers You**:

- Career development opportunities so you can achieve your goals
- A supportive team
- A thriving environment that makes you feel valued
- Equal opportunities employer:_