Senior Clinical Research Associate

vor 2 Wochen

Salzburg, Österreich CROMSOURCE Vollzeit

CROMSOURCE is recruiting for 2 Freelance CRAs to join our team in Germany. You will be responsible for full site management from feasibility to close out of studies. We have a varied client base, ranging from small-mid-sized Pharma and Medical Device companies. Work at home and site visits.

**Site Location**:Essen, Cologne, Heidelberg, Ulm, Leipzig, Munich and Karlsruhe (sites divided to accommodate travel)

**Schedule**: 0.5 - 0.7 FTE

**Main Job Tasks and Responsibilities**
- Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
- Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance
- Adapts and translates Patient Information Leaflets and Informed Consent Forms
- Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
- Escalates any issues to relevant project team members
- May assist in contract negotiation with sites on study budget after appropriate and documented training
- May support the submission process in the project (or region)

**Education and Experience**
- You have a University Degree in scientific medical or paramedical discipline
- Prior experience as a CRA
- Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirement
- Fluent in English
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
- Willingness to travel

**The Application Process**

**_Who will you be working for?_**

**_About CROMSOURCE_**

Do you want to join a team that is passionate about making a difference in drug and medical device development?

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

**_Our Company Ethos_**

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

**Job Types**: Part-time, Contract
Contract length: 12 months
Part-time hours: 20 per week

Application Question(s):

- Are you willing to travel? Sites located in Essen, Cologne, Heidelberg, Ulm, Leipzig and Munich. You only go to the sites assigned to you.

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