Clinical Research Associate
hace 2 semanas
**Allucent**:
**Remote, Spain**:
**Responsibilities**:
- Perform initiation visits to train and instruct site staff on the study specific requirements;
- Assist in site activation;
- Perform Monitoring visits to:
- Verify that source data and study database are accurate, complete and maintained properly;
- Verify protocol compliance, including safety reporting and drug handling;
- Verify all study files are maintained and up to date.
- Support site staff in preparation for study specific site audits and inspections;
- Perform Close-out visits;
- Perform Pre-study visits, if delegated by SSU;
- Perform centralized and risk based monitoring activities;
- Act as the main line of communication between the study PM/LCRA and the site staff;
- Maintain study related trackers;
- Prepare site visit reports;
- Liaise with site staff to achieve patient recruitment targets;
- Contribute to the development of study specific documents;
- Support the study start-up team in preparation of the submission packages and collection of site documents, if delegated by SSU;
- Actively support site management staff learning & development within the company.
**Requirements**:
- Life science, healthcare, medicine and/or related degree;
- Minimum 1-2 year of CRA experience;
- Minimum 1-2 years of experience in drug development and/or clinical research;
- Good knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements;
- Good understanding of site management and monitoring;
- The ability to perform site visits in an effective way and according to high quality standards.
**Skills**:
- Strong written and verbal communication skills including good command of local and English language;
- Representative, outgoing and client focused;
- Ability to work in a fast-paced challenging environment of a growing company;
- Administrative excellence with attention to detail and accuracy;
- Strong organizational skills.
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