Location: Italy - Home based
Schedule: Part-time, Contract
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds….
TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for an experienced Clinical Research Associate (CRA) to join one of our partner companies, a pharmaceutical company involved in a wide range of therapeutic areas.
CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Scope of the role:
As a CRA you are of course passionate about clinical trials. You manage your work independently, but at the same time you work in collaboration with trial team members on one of the clinical trials.
Main Job Tasks and Responsibilities:
- Visit study sites for monitoring visits
- Review of investigator site files, source records and quality checks
- Possibly also for remote monitoring of the eCRF
- Roughly 20-30 sites running in Italy during 2021
- Plan additional sites in the coming years, no end-date has yet been defined
- Coordinating with cross discipline team members to make sure that all parties are on track with project requirements, deadlines, and schedules
- Submitting project deliverables and ensuring that they adhere to quality standards
- Input clinical research data into electronic data systems
- Monitor study sites and activities to ensure the appropriate industry protocols and terms of the study are being followed
- Create thorough documentation of study protocol and update it as needed
Education and Experience:
- Preferably life sciences degree with experience in a clinical research/healthcare environment or qualified nurse/healthcare professional
- Ideally at least 2-3 years of experience as CRA
- Detailed knowledge of required procedures for monitoring clinical trials and of GCP; and local regulatory requirements
- Knowledge of the local and international law relating to the conduct of clinical research
- Current/Valid ICH-GCP training
- Familiar with medical terminology
- International and intercultural work experience is beneficial
- Advanced English and local language skills (spoken and written) any other European language is an asset
Specific Role Requirements and Skills:
- Excellent verbal and written communication skills
- Well-developed communication skills
- Ability to work in an international team
- Organisational skills
- Knowledge of project management principles
- IT skills (word, excel, power point)
- Accuracy & attention to detail
- Collaboration & teamwork
- Pro-active and Flexible
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact firstname.lastname@example.org for more information.
Who will you be working for?
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.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
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: Clinical Research Associate, Freelance, Freelancer, Monitoring, GCP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated
Clinical Research Associate, Freelance, CRO, GCP, Monitoring Visit