Clinical Research Associate
Il y a 3 mois
**_We believe there is a smarter, more data-driven way to make decisions in health._** As we pass 1,200,000 genomic profiles analyzed and look to the future of our platform, we are now searching for a Clinical Research Associate who will help in transitioning our platform to the next level.
Our mission is to bring data analytics solutions to market, to support healthcare professionals by maximising the power of Data-Driven Medicine. SOPHiA GENETICS (NASDAQ: SOPH) combines collective intelligence in Genomics, Radiomics, clinical research data, the DDM - Data-Driven Medicine, we can ensure that the data used to help patients today will also benefit the patients of tomorrow.
The** Clinical Research Associate **reports to the Sr. Director, Clinical Operations.
This role supports the execution and monitoring of clinical study management efforts at SOPHiA GENETICS and assists the Clinical Operations team in completion of all required tasks to meet departmental and projects goals.
**Main responsabilities**:
- Conduct site pre-selection visits (SPSV), site initiation visits (SIV), on site and remote monitoring visits (SMV/RMV) and close out visits (COV) at assigned clinical sites and generate visit reports within the timelines sets in study plans.
- Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and applicable regulatory requirement(s).
- Ensure the quality and integrity of the data collected and reported by assigned sites
- Works with the Clinical Project Manager and Lead CRA to proactively manage site visits and any study related activities or issues during the startup and monitoring phase.
- Maintains Trial Master File (TMF) as defined per appropriate regulations, study plans and processes.
- Provide operational support for all trial-related activities and for assigned sites (e.g., payments, tracking, reporting, etc.)
- Participate to and support Medical and Clinical Operations initiative and projects while constantly sharing feedback/proactively proposing improvements/changes when applicable.
**Requirements**:
- 1 to 3 years’ experience in clinical research is mandatory: Either as a CRA in CRO/Biotech or pharma company, or within a clinical research unit/hospital as a study coordinator, technician, nurse
- Solid knowledge of clinical trial processes and ICH/GCP guidelines
- Basic knowledge of Oncology trials
- Well organised with good time management skills
- Willingness to undertake travel about **30% of time**:
- Excellent spoken and written French and English skills. Other languages are a plus
- Strong ability to work in cross-functional teams
- Team-oriented spirit
- Excellent communication skills
- Ability to build strong site relationships
- Ability to work in constant growing and changing environment
**Benefits**
**You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we drive exponential growth.**
**Business recognition and accolades include**:
- World's most innovative companies (Top 10)
- World's smartest companies (Top 50)
- 100 Best Places to Work in Boston
- Top 10 European Tech Startup - 2020
- Top 10 European biotechs startup to watch - 2021
- Top 25 East-Coast Biotech to watch - 2021
**Plus, if you join our Bordeaux office, you will find**:
- Flexible, friendly and international working environment
- An exciting journey to facilitate patients' access to better treatment worldwide
- A stimulating technical environment
- Continuous learning and trainings
- A competitive salary
- Vacation bonus in June
- Onboarding program and Welcome kit for new joiners
- Health Insurance
- Meal vouchers card
- New amazing office space in Bidart, near Biarritz located between the mountains and the ocean - 20 minutes from Spain border
**Location**:This position could be based in **Bordeaux** office (France) or** fully remote (in France)**,
**Start Date**: ASAP (or as agreed)
**Contract type**: Permanent
**Application process**:
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