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!
- 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
- Fluency in English is required. Knowledge of other European languages a plus
- Previous CRA experience is required
- A background in ophthalmology is a plus
+32 10 68 53 30
- The role is 4d/w office based in Munich, 1d/w remote