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Clinical Research Associate - Freelance

  • TFS
  • Full time
  • France
  • 02/05/2021

TFS is a Global CRO headquartered in Sweden. We genuinely believe that "Global in mind and local at heart" is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.

We are currently looking for experienced personnel with Oncology therapeutic experience and ability to assist in other therapeutic areas when needed.

The Clinical Research Associate (CRA) is part of Clinical Monitoring within TFS and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct according to company policies, SOPs and regulatory requirements

Key responsibilities include:

  • Monitor on-site 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
  • 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
  • Participate in contract handling and negotiation directed by Lead CRA/Project Manager
  • Set up ISF and SMF and distribute to the investigational sites

Requirements

  • Bachelor's degree preferably in life science or nursing or equivalent experience
  • 3-5 years of experience as a CRA including relevant experience in Oncology therapeutic area
  • 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
  • Ability and willingness to travel 60-70%

Benefits

  • Competitive rate
  • Flexible hours
  • Working on various studies and therapeutic areas

About TFS

We believe that a company with ethical and transparent values has a better chance of attracting skilled employees and building long-term relationships.

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