Job FunctionFreelance CRA/PM [ingevuld door Carpe Diem]
Short DescriptionFor a cardiovascular study my client is looking for an experienced freelance CRA for at least 6 months.
Company ProfileA growing company with a large diversity in local and international trials.
Function Profile- Involved in the start-up of the study and carry out pre-study visits
- 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 for completeness and accuracy by verifying the source documents
- 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’
- Ensures that information is conveyed effectively between the sponsor, investigator and project team
- Collaborates closely with internal and external contacts

Function Criteria- Higher level of education preferably in an (bio)medical field
- At least 5 years of clinical research monitoring experience, preferably with international trials
- Up-to-date knowledge of legislation and regulations and ICH/GCP guidelines
- Fluency in Dutch and English
- Flexible, proactive and results orientated
- Excellent organizational, record retention and time management skills
- Passion for customer service

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