Experienced Clinical research associate (Germany)

For one of our clients in Munich, we are urgently looking for an experienced CRA.

  • Do you have a thorough experience as CRA ?
  • Are you independent, communicative and quickly available?
  • And are you fluent in English?

Then you are the ideal candidate for this position! Don’t hesitate, and apply as soon as you can!

Responsibilities 
  • Investigator and CRO selection
  • Ensures IP processes (ordering, labelling, release, destruction)
  • Takes part in the protocol review- mainly operational parts
  • Compiles independently various study documentation i.e. informed consent forms, CRFs, study product accountability forms, Investigator Site Files and Trial Master Files
  • Takes part in investigator/ site selection and conducting pre-study visits
  • Ensures that sites have all protocol related supplies (in addition to IP) to start the study
  • Coordinates site contract activities (eg signature process) as needed
  • Train site personnel
  • Plan and executes study initiation and monitoring visits
  • Ensures that the study is conducted according to effective legislation, SOPs, ICH-GCP-guidelines and study protocol
  • Shares real time information between study site and the client
  • Ensures that the patient selection is appropriate
  • Follow-up the subject recruitment regularlyReview data (individual, aggregate), Source data verification
  • Follow-up the Serious Adverse Event reporting
  • Verifies that the study data is delivered to data management within agreed timelines
  • Prepares monitoring reports within agreed timelines or reviewing the reports prepared by the CROs
  • Actively participates in the review, evaluation and reporting of clinical data
  • Checks the study product accountability
  • Ensures that there are no delays in study data transfer to data management
  • Ensures TMF completeness and proper archiving of study documentation
  • Conducts study close-out visit
Profile 
  • Fluency in English is required. Knowledge of other European languages a plus
  • Previous CRA experience is required
  • A background in ophthalmology is a plus
Contact Information 

Ariane d'Ansembourg
+32 10 68 53 30
ariane.dansembourg@valesta.com

Important 
  • The role is 4d/w office based in Munich, 1d/w remote

Application form : Experienced Clinical research associate (Germany)

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