CRA - France

Location: France - Remote, France, Spain
Date Posted: 10-12-2018
Headquartered in Aventura, Florida, with regional offices and operations across North America and around the world, Biorasi is an award-winning fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies. Biorasi hires talent and personality, not position holders. We’re a non-traditional work environment requiring only top performers. Every team member is a stock-holding owner and our culture reflects it. Unlimited potential for professional, financial and personal growth. If you are after broad and growing responsibilities coupled with full authority, are keen on doing the job your way, without bureaucracy getting in the way of key decisions, and truly believe that a well-structured operational infrastructure is one of the key components to a company’s success, then this unique opportunity is for you. This is a remarkable opportunity to dedicate yourself to leading a vital function of a growing company and benefiting professionally and financially from your accomplishments. If you have an entrepreneurial mind-set, a passion for achievement and are looking for a place to explore your potential, Biorasi wants to talk to you now.

The Role

The Clinical Research Associate’s (CRA) primary objective is to ensure investigational research sites conduct all study procedures according to the protocol, GCP, SOPs, and other applicable regulatory requirements. From site selection to closeout, the CRA will oversee the day-to-day execution of the study and monitor clinical data in order to verify the overall quality of the study. Responsibilities include, but are not limited to the following:
• Participates in the selection and initiation of investigative sites and ensures sites are adequately trained and resourced to conduct the clinical study appropriately.
• Works in close liaison with investigative personnel to provide clinical site management and escalate major issues to the project management team.
• Performs source data verification, query resolution, regulatory document review, and Investigational Product accountability during site monitoring visits.
• Identifies AE/SAEs and ensures all applicable safety observations are properly documented and reported to the Sponsor and/or Institutional Review Board
• Writes and finalizes monitoring visit reports according to internal guidelines.
• Contributes to the clinical team development by mentoring and training new members. Candidate Profile • Bachelor Degree in biomedical sciences or related scientific discipline.
• Minimum of 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience.
• Thorough Knowledge of FDA regulations and ICH guidelines.
• Ability to travel up to 80%, depending on project requirements.
• Proficient computer skills, including knowledge of MS Office.
• Excellent communication skills, both written and verbal.
• Ability to multi-task with attentiveness to detail.
• Fluency in written and spoken English.
  • This is remote based position, reporting to our office in Germany and US.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Required experience:
Clinical Research : 2 yreas
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