Clinical Trial Assistant

**Location**: Verona, Italy
**Schedule**: Full-time, permanent

Do you want to join a team that is passionate about making a difference in drug and medical device development? CROMSOURCE, a growing CRO, are looking for a dynamic person to join our in-house team as **Clinical Trial Assistant**. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.

**Main Job Tasks and Responsibilities**:

- Cooperates with the project team, accurately updating and maintaining clinical tracking systems
- Responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports
- May act as Feasibility Associate (FEA) after appropriate and documented training
- Collaborates with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project)
- Prepares and requests the necessary local authorities approvals
- May support the project team in managing the agreements with hospitals and investigational centers
- Assists with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
- Collaborates with the project team in organizing Investigator's and Monitor's Meetings
- Collaborates with the project team in managing the follow-ups of the monitor's activities
- Manages the telephone monitoring of projects
- Collaborates with the project team in managing the payments of sites
- May perform submissions to local ECs and CAs
**Education and Experience**:

- University Degree in scientific medical or paramedical discipline
- One/three years of Clinical Research experience in the CRO/Pharmaceutical industry
- Good Knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
- Experience in Submission Process and Investigational Sites Financial Agreements Management
**Specific Role Requirements and Skills**:

- Fluent in Italian and English
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
- Resistance to stress
- Pro-activity
- Flexibility
- Ability to work in a team
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- Ability to motivate both individually and collectively
- Excellent problem solving capability through early identification
- Demonstrate, appreciation and understanding of finance and budgeting issues
- Competent in written and oral English
**Our Benefits**:

- Meal vouchers
- Mobile phone if requested by the Line Manager
- Dedicated Line Manager
- Monthly meetings with line manager
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
**The Application Process**

**Who will you be working for?**

**_About CROMSOURCE_**
CROMSOURCE is a family owned international, full-service Contract Research Organisation 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.

**Key words**: CTA, Clinical Trial Administrator, Clinical Trial Assistant, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, submissions, Clinical Research ICH-GCP, Monitoring

**Job Types**: Full-time, Permanent

**Education**:

- Bachelor's (required)
**Experience**:

- Clinical Trial Assistant: 2 years (required)
- Submission Process: 2 years (required)
- eTMF: 1 year (required)