Clinical Research Associate
We are seeking a highly motivated and experienced Clinical Research Associate to join our team at AventaMed.
About the Role
In this exciting opportunity, you will be involved in designing, planning, implementing, and managing clinical research projects. Your goal will be to ensure compliance with the protocol and overall clinical objectives, as well as applicable SOPS and regulations.
Responsibilities
* Assist the activities of interdisciplinary team members in the planning, execution, and closure of pre-market and post-market clinical studies.
* Develop and approve study-specific documents, tools, presentations, and processes.
* Prepare ethics submissions and study-specific documents such as protocols, patient information leaflets, informed consent forms, and case report forms.
* Maintain Trial Master Files and Investigator Site Files for multiple studies.
* Prepare and present at Investigator meetings.
* Participate in site qualification, study initiation, and study closure process.
* Assist with the management of medical device tracking and accountability.
* Create and maintain study databases, including data entry, routine review of data/CRFs to ensure data integrity, accuracy, and protocol compliance.
* Track and report progress of studies to applicable internal stakeholders.
* Develop study reports and provide clinical reports for regulatory submissions.
Requirements
* Bachelor's degree in Science or related disciplines.
* Minimum 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.
What We Offer
* Competitive salary and bonus.
* Pension and excellent healthcare benefits.