Clinical Trial Associate
hace 2 semanas
Overview:
TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Clinical Trial Associate (CTA) who shares our vision of providing clinical research excellence.
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.
Together we make a difference.
TFS HealthScience is looking for a Clinical Trial Associate (CTA) hybrid based in Barcelona.
This role will sit embedded within one of our prestigious clients who promotes rapid career development
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 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.
Benefits include:
Lunch allowance
Health Insurance
Flexible working times
Home allowance
Flexible remuneration
Responsibilities:
Work with the Study Team in initiating, maintaining and closing/final archiving of the SMF,
ensuring GCP compliance
- Set up and maintenance of study information in Clinical Trial Management System (CTMS)
- Maintenance of electronic files
- Set up the Investigator's File as directed by the CRA
- Point of contact regarding SMF
- Maintain the SMF as directed by the Lead CRA/Project Manager
- Coordinate study supplies as directed by the CRA
- Drafts and/or assists with the preparation of trialrelated documents, tools and templates
- Assist in status reporting
- Arrange internal and external meetings
- Actively taking part in Study Team meetings and be responsible for the minutes
- Prepare, contribute to and distribute presentation material for meetings and newsletter
- Assist in activities associated with audits and regulatory inspections
- SMF completion and preparation of shipment to sponsor as directed by the Lead CRA /CRA
- Collection of appendices for final Clinical Study report
- Actively contribute to the organization and development of routines to enhance the work at
TFS
- Work with the Study Team in all regulatory process (IEC/IRBs/CA ) including submission and
- Assist the CRA, PM or Lead CRA managing contracts with sites, including contract status.
- To manage Investigator Payments as directed by PL or Lead CRA
- Assist the PL with document translations process
- May support the CRAs with some monitoring remote activities: collection of documentation,
Qualifications:
Bachelor's Degree preferred
- Knowledge of GCP/ICH guidelines, 6months1year experience working in the role
- Good written and communication skills
- Good organizational skills
- Good software and computer skills
- Able to work in a fast paced environment with changing priorities
- Fluent English
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TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _
- for further details._
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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 benefits._
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