Clinical Research Associate (Home based - Italy)
TFS, Italy
Job Description
TFS HealthScience is excited to be expanding our Site Management team and we are looking for an experienced, highly motivated Clinical Research Associate (CRA) who shares our vision of providing clinical research excellence. Our Site Management team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.
TFS HealthScience is looking for a Clinical Research Associate (CRA)home or office based in ITALY. We look forward to receiving your application!
The Clinical Research Associate (CRA) is part of Clinical Operations or Strategic Resourcing Solutions Unit and is responsible for the initiation, onsite and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements.
Key Responsibilities
- Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines Review CRFs and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data.
- Review Informed Consent documents for essential elements and protocol specifics
- Update CTMS system with site and study information
- Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data.
- Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos and verbal communication with Project Manager or Lead CRA.
- Initiates corrective action to resolve issues as directed by supervisor.
- Contribute to the completion of the application to Ethics Committee/ IRB and prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager.
Disclaimers:
TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the?privacy notice?for further details.
TFS HealthScience does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and be
Requirements
- Bachelor's degree preferably in life science or equivalent experience
- 3-5 years of experience as a CRA
- 1 year of ophthalmology experience
- Ability and willingness to travel 60-70%
- Able to work in a fast-paced environment with changing priorities
- Ability to work independently as well as in a team matrix organization
- Excellent verbal and communication skills
- Excellent organizational skills
Benefits
What can we offer you??
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS HealthScience is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. Italy benefits include:?
- Competitive salary amp; benefits package?
- Excellent career progression opportunities?
- Great corporate culture and work life balance?