Clinical Research Associate 2

hace 3 meses

Barcelona, España Veranex, Inc. A tiempo completo

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

**About This Role**:
Veranex has an exciting opportunity to join our team as a Clinical Research Associate. You will be part of a team working to improve lives globally through medical technology innovation. The Clinical Research Associate will be responsible for organizing and overseeing clinical studies and ensuring the studies are conducted, recorded, and reported in accordance with all applicable regulatory requirements, good clinical practice (GCP), the study protocol and standard operating procedures (SOPs).

**What You Will Do**:

- Acts as project resource to clinical site, sponsor, and internal stakeholders regarding the product under investigation and the clinical study conduct
- Supports study activities to meet protocol and client objectives, maintaining regulatory compliance and professional integrity for clinical studies
- Contributes to the development of study documentation, e.g., protocol, informed consent, case report form (CRF) and study specific plans (monitoring plans, data management plans) as well as annual progress reports (APRs) and the clinical study report (CSR).
- Manages and maintains the documentation of all clinical study activities in the study Trial Master File
- Confirms data quality/integrity by participating in site qualification and monitoring visits (site initiation, monitoring, and site close-out), reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary
- Establishes regular lines of communication and assists with administration of protocol and related study training to assigned sites

**Qualifications**:
**Required skills**:

- Bachelors’ degree in life sciences or related discipline
- 2-4 years’ relevant work experience in the medical device field
- Strong knowledge of Good Clinical Practice (ISO 14155) and/or Good Study Practice (ISO 20916)
- Good knowledge of the European regulations MDR (EU 2017/745) and/or IVDR (EU 2017/746)
- Good written and oral communication skills in English
- Good organizational and time-management skills
- Excellent attention to detail
- Ability to multitask and prioritize work
- Good ability to work in cross-functional teams
- Able to travel (25-50%)

**Preferred**:

- Good knowledge in risk assessment
- Good knowledge in statistics
- Other languages such as French, German and Italian a plus
- Takes a proactive approach to work
- Good knowledge in cardiology
- IVD experience

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