Apply your creativity and passion to develop innovative medical devices that can greatly improve patients' lives. We take pride in a truly entrepreneurial environment, unique technical challenges and a collaborative culture. We welcome you to explore Avation and be part of a talented R&D group and an exciting company.
As a Clinical Research Associate/Clinical Monitor, you will be a part of the Clinical Team and provide support for the execution of our clinical strategy by conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP, and all applicable local and federal laws and regulations.:
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; and other duties as assigned.
- Establishing regular lines of communication plus administering protocol and related study training to assigned sites.
- Evaluating the quality and integrity of site practices-escalating quality issues as appropriate.
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Bachelor's Degree in relevant scientific, clinical or engineering discipline.
- 1 to 3 years of experience as a Clinical Research Associate/Clinical Monitor.
- Sound knowledge of ICH/GCP and regulatory requirements.
- Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
- Energy and enthusiasm; candidates should find the work "fun", and have a passion for innovation and in saving and improving lives in neurotechnology.
- Must possess the initiative to get results, and a "whatever it takes" attitude to do what's necessary to accomplish team objectives with integrity.
- Proficient working knowledge of MS Word, PowerPoint, Excel and data management software programs.
- Medical device, neuroscience, start-up experience a plus.
- Fluent in English, spoken and written
- Travel up to 70% to support study sites.
We are seeking candidates who are.:
- Driven by the desire to bring innovative medical technologies to market that will improve the lives of patients.
- Passionate about applying themselves to improve the lives of patients.
- Intellectually curious, motivated by innovation and open to new ideas.
- Leaders who take individual ownership while placing high value on teams.
- Energetic and enjoy working in a fast-paced environment.