Freelance Clinical Research Associate

vor 3 Wochen

Munich, Deutschland Talent Source Vollzeit

Description:
**Location**: Frankfurt/ Munich area, Germany, Home-based

**Schedule**: Freelance - 0.5 - 0.7 FTE

CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a
- **Freelance Clinical Research Associate**

In this role, 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.

Join our team and help us deliver clinical trials that will improve patients' lives.

**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 to ensure protocol/ICHGCP compliance.
- Adapts and translates Patient Information Leaflets and Informed Consent Forms
- Cooperates with the site staff to ensure proper reporting from the site of the safety issues (adverse events and adverse reactions 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 the 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 Organisation that, 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 can 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 all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry-average turnover rates.

CROMSOURCE is an equal opportunity 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.

**Keywords**: CRA, Clinical Research Associate, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, submissions, Clinical Research ICH-GCP, Monitoring, Home based, Germany, Deutschland

**Skills**:Clinical Research Associate, Freelance, clinical trials, ICH-GCP, Monitoring

Location: Germany

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