Clinical Research Associate Jobs

This is a new role, you will be responsible for driving and overseeing the day to day operations of clinical trials and studies (investigator initiated trials and company sponsored trials).

Your responsibilities:

• Select, establish and manage the relationship with contract research organizations (CROs)
• Oversee the smooth running of clinical trials as per protocol, in accordance with regulatory and ethical standards.
• Support the process of the protocol definition with internal and external stakeholders
• Write, amend, and submitt clinical trial documentation to partners and ethical committees and accompanying patient information material
• Train the study team on study protocol and on proper usage of company medical products
• Collect, and organizing documents and data obtained from research according to best practices for data privacy and regulatory compliance (as per FDA / MDR guidelines)
• Contribute to the management of assigned budget
• Liaise between study team and clinical and product development teams to provide technical support and continuous feedback

Qualifications

• Experience in developing and managing clinical trial budgets, as well as in working with external contract research organizations
• Superior analytical and organizational skills: attention to detail and accuracy
• In-depth knowledge of ICH-GCP, the Medical Device Directive: understanding of US and European medical device clinical trial approval procedures
• Training/experience in neuroscience/neuro-engineering/neurorehabilitation is a plus
• Fluent level of English
• Proven experience (5+ years) in clinical project execution, preferably in (neuro)rehabilitation and medical device industry; experience with Software as Medical devices (SaMD) and training in project management is a plus
• Bachelor's degree in biomedical, nursing or a related field
• Very good written, verbal, and interpersonal communication skills

Additional Information

Please note that the job title listed in this posting is not set in stone and may be adapted to better reflect the skills and experience of the ideal candidate

Benefits Overview

• Health Insurance
• Health savings account
• Dental insurance
• 401(k)
• Flexible schedule
• Flexible spending account
• Life insurance
• Paid time off
• Employee discount
• Vision insurance
• 401(k) matching

Mindmaze provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.