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kappa

Clinical Research Assistant – Freelance home-based (Spanish speaking)

Offre publiée le mercredi 5 janvier 2022

Our company:

Kappa Santé is a french research Contract Research Organisation (CRO) specialized in epidemiology and public health, providing services to pharmaceutical industry and health institutions. Monitoring the health status of the population, demonstrating causal relationships between a factor and a disease, developing prevention strategies, evaluating health systems, measuring the impact of actions on public health, and evaluating the use and safety of drugs are all missions entrusted to modern epidemiology.

 

Position description:

For a new international non-interventional research project in France and Spain, we are looking for two home-based freelance CRAs fluent in Spanish (from 0.5 to 1 FTE) to reinforce our operational teams until mid-2023. In addition to Spanish, fluency in French and/or English is required.

The activities/tasks to be performed in relation to the study shall consist of:

  • Assist the regulatory department with collection of essential documents
  • Assist the regulatory department to perform submissions to Competent Authorities and Ethic Committees for initial approval and further life cycle management
  • Perform contract and budget negotiations for the Spanish participating sites
  • Performing site qualification, initiation, monitoring, remote review and close-out visits per monitoring plan (remote)
  • Writing monitoring reports and follow-up letters;
  • Adverse event and serious adverse event follow-up and assistance as required
  • Investigator meeting attendance and participation
  • Site management and support as determined by monitoring plan, and Clinical Monitoring Department Management
  • Other duties as requested by Clinical Monitoring Management

You will work in close collaboration with the Kappa Santé operational team including senior lead CRA in Spain, and will be supervised by the Clinical Project Manager and the CRA Manager.

 

To become part of our team, you should:

  • Be fluent in Spanish, and either French or English.
  • Have a degree in Life Sciences or have equivalent experience.
  • Have at least 2 years of independent CRA experience.
  • Have in depth GCP knowledge
  • Be flexible with 0.5 to 1 FTE

Position offered under home-based freelance contract; access to our premises in Paris is possible. Bill rate to be discussed according to qualifications.

Start date: January 2022.

Contact information:

Kappa Santé

4 rue de Cléry, 75002 Paris. France.

Tél : (+33)1 44 82 50 13

Email : raphael.germain@kappasante.com

Offre publiée le vendredi 14 janvier 2022
Offre publiée le vendredi 14 janvier 2022
Offre publiée le vendredi 14 janvier 2022
Offre publiée le vendredi 14 janvier 2022
Offre publiée le vendredi 14 janvier 2022

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