Job Title: Clinical Research Associate
Aventa Med Rubicon Centre, Bishopstown, Cork
Benefits:
* Competitive Salary
* Bonus
* Pension
* Healthcare
Company Background:
Aventa Med has recently been acquired by Karl Storz and developed a breakthrough single-use medical device, Solo+TTD that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear.
The surgical tympanostomy is the most common procedure done on children.
Job Overview:
In this role, you will be involved in 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.
Key Responsibilities:
1. Assisting the activities of interdisciplinary Aventa Med team members in the planning, executing, and closing of both pre-market and post-market clinical studies.
2. Developing and approving study-specific documents, tools, presentations, and processes.
3. Prepare ethics submissions and study-specific documents such as protocols, patient information leaflets, informed consent forms, and case report forms.
4. Maintain Trial Master Files and Investigator Site Files for multiple studies.
5. Preparing and presenting at Investigator meetings.
6. Participating in the site qualification, study initiation, and study closure process.
7. Assisting with the management of medical device tracking and accountability.
8. Creating and maintaining study databases, including data entry, routinely reviewing data/CRFs to ensure data integrity, accuracy, and protocol compliance.
9. Tracking and reporting progress of studies to applicable internal stakeholders, including patient screening, enrolment, data collection, adverse event documentation, and reporting.
10. Developing study reports and providing clinical reports for regulatory submissions.
11. Perform monitoring and site visits, including preparation of site visit, data query, adverse event, and study deviation reports.
12. Acting as a company liaison to work with clinical sites, Contract Research Organizations (CROs), Site Management Organizations (SMOs) and other vendors/consultants.
13. Maintaining familiarity with all applicable regulatory requirements and relevant clinical literature.
14. Maintaining compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21 CFR820, Declaration of Helsinki, Data Protection Act, and any other clinical study/trial regulations.
Requirements:
Bachelors 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 21 CFR820, 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 organized, 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.