Job Opportunity
We are seeking a highly skilled Clinical Research Associate to join our team. In this role, you will be responsible for designing, planning, implementing, and managing the overall conduct of clinical research projects.
Key Responsibilities:
* Assist in the planning, execution, and closing of pre-market and post-market clinical studies.
* Develop and approve study-specific documents, tools, presentations, and processes.
* Maintain Trial Master Files and Investigator Site Files for multiple studies.
* Prepare ethics submissions and study-specific documents such as protocols, patient information leaflets, informed consent forms, and case report forms.
* Track and report progress of studies to applicable internal stakeholders including patient screening, enrolment, data collection, adverse event documentation, and reporting.
* Develop study reports and provide clinical reports for regulatory submissions.
* Perform monitoring and site visits including preparation of site visit, data query, adverse event, and study deviation reports.
* Act as a liaison to work with clinical sites, Contract Research Organizations (CROs), Site Management Organizations (SMOs), and other vendors/consultants.
Requirements:
* Bachelor's degree in Science or related disciplines with a minimum of 4 years of experience in the medical device industry.
* Experience in pre-market and post-market clinical studies of medical devices essential.
* Clinical certifications desirable.
* Thorough understanding and knowledge of ISO 13485, ISO 14155, ICH GCP, US 21CFR820, and EU MDR.
* Proven track record with the ability to successfully manage projects to deadlines.
* Strong ability to manage critical projects as part of an interdisciplinary team.
* Excellent problem-solving and communication skills.
* Self-motivated, highly organized, and detail-oriented.
* Excellent oral and written communication skills.
* Able to work as part of a cross-functional team.
What We Offer:
A competitive salary, bonus, pension, healthcare, and excellent opportunity to develop your experience and career in an exciting company.
Our breakthrough single-use medical device addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear.
We thrive in a fast-paced / entrepreneurial environment and welcome applications from individuals who share our values.