Job Title: Clinical Associate
Location: Bishopstown, Cork
Benefits: Excellent salary, bonus, healthcare and pension.

Company:
My client are a medical‐device company specialising in ENT (Ear, Nose & Throat) innovations. Their goal is to simplify surgical procedures in ENT, improving patient safety, reducing costs, and shifting some procedures out of the operating room environment. The company was spun out of Munster Technological University (earlier Cork Institute of Technology) in 2015, based on research from the Medical Engineering Design & Innovation Centre (MEDIC).

The Role:
The role of Clinical Research Associate will involve designing, planning, implementing, and managing the overall conduct, or particular elements, of clinical research projects. The goal of the CRA is to ensure compliance with the protocol and overall clinical objectives as well as applicable SOPS and regulations. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential.

Ideally you will:

• Be passionate about managing clinical studies for state-of-the art implantable medical devices
• Be energised by working for a world-class manufacturer and collaborating on cross-functional teams
• Recognise the importance of building and maintaining strong interpersonal relationships.

• Assisting the activities of interdisciplinary company team members in the planning, executing and closing of both pre-market and post-market clinical studies
• Developing and approving 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
• Preparing and presenting at Investigator meetings
• Participating in the site qualification, study initiation and study closure process
• Assisting with the management of medical device tracking and accountability
• Creating and maintain study databases, including data entry, routinely reviewing data/CRFs to ensure data integrity, accuracy and protocol compliance
• Tracking and reporting progress of studies to applicable internal stakeholders including: patient screening, enrolment, data collection, adverse event documentation and reporting
• Developing study reports and providing clinical reports for regulatory submissions
• Perform monitoring and site visits including preparation of site visit, data query, adverse event and study deviation reports
• Acting as a company liaison to work with clinical sites, Contract Research Organisations (CROs), Site Management Organisations (SMOs) and other vendors/consultants
• Maintaining familiarity with all applicable regulatory requirements and relevant clinical literature
• Maintaining compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki, Data Protection Act and any other clinical study/trial regulations.
• Carry out other clinical related duties as required.
• Carrying out activities related to QMS documentation control as required.

• Bachelor’s degree in Science or related disciplines with a minimum of 3 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
• Must be self-motivated, highly organised and detail oriented
• Excellent oral and written communication skills
• Must be able to work as part of a cross functional team
• Thrives to work in a fast-paced / entrepreneurial environment