Job FunctionNIEUW: CRA met internationaal monitoren
Short DescriptionVoor mijn klant ben ik op zoek naar een CRA met minimaal 2 jaar ervaring en interesse in frequent internationaal monitoren.
Company ProfileEen groeiende organisatie met een grote diversiteit aan lokale en internationale trials.
Function Profile- Monitors clinical research in accordance with the protocol, SOPs, applicable laws and ICH-GCP guidelines, including visit report compilation and follow-up within the set timelines;
- Collates and verifies the Case Report Forms (CRFs) for completeness and accuracy by verifying the source documents, e.g. medical file, laboratory results;
- Ensures the correct query process is followed in collaboration with the Data Management team;
- Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;
- Verifies compliance with procedures relating to drug accountability;
- Develops and maintains an effective working relationship with site staff;
- Trains investigators and site staff (including laboratory, pharmacy and other staff involved) in the correct implementation of the protocol, the CRF and study-specific procedures;
- Supports the investigator during inspections by healthcare authorities or audits;
- Ensures the reliable documentation and archiving of study documents, both at the investigator and ‘in-house’;
- Participates in and helps to organise meetings for investigators and CRAs;
- Ensures that information is conveyed effectively between the sponsor, investigator and project team;
- Collaborates closely with internal and external contacts;
- Is involved in SOP development, maintenance and training.
Function Criteria- Higher level of education, preferably in an (bio)medical field;
- At least two years of relevant experience in clinical research;
- Knowledge of legislation and regulations and ICH-GCP guidelines;
- Effective oral and written communication skills in English and Dutch;
- Proactive, strong communication and negotiations skills;
- Willingness to travel;
- Ability to work independently as well as in a team matrix organisation.

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