Clinical Research Associate

Scientificjobs; Cork; On-site; EUR 40,000 - 65,000; Full time

Job summary

A leading company is seeking a Clinical Research Associate in Cork, involved in managing clinical studies for innovative medical devices. This role offers competitive salary and benefits, excellent career development opportunities, and the chance to work in a fast-paced environment focused on groundbreaking healthcare solutions.

Benefits

Competitive Salary

Bonus

Pension

Healthcare

Qualifications

• Minimum of 4 years experience in the medical device industry.
• Experience in pre-market and post-market clinical studies essential.
• Strong ability to manage critical projects.

Responsibilities

• Manage the conduct of clinical research projects compliant with protocols.
• Prepare study-specific documents and maintain Trial Master Files.
• Perform monitoring and site visits, ensuring data integrity.

Skills

Project Management

Communication

Problem Solving

Education

Bachelor’s degree in Science or related disciplines

Job description

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Job Title: Clinical Research Associate
Location: Bishopstown, Cork

Benefits:
Competitive Salary, Bonus, Pension, Healthcare + Excellent opportunity to develop your experience and career in an exciting company.

Company:
My client have recently been acquired and have developed a breakthrough single-use medical device, 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.

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.

The ideal candidate will:

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

Job Title: Clinical Research Associate
Location: Bishopstown, Cork

Benefits:
Competitive Salary, Bonus, Pension, Healthcare + Excellent opportunity to develop your experience and career in an exciting company.

Company:
My client have recently been acquired and have developed a breakthrough single-use medical device, 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.

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.

The ideal candidate will:

Be passionate about managing clinical studies for state-of-the art implantable medical devices

Be energized by working for a world-class manufacturer and collaborating on cross-functional teams

Recognise the importance of building and maintaining strong interpersonal relationships

Responsibilities:

Assisting the activities of interdisciplinary AventaMed 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 Organizations (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.

Education

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

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

Does this sound like your next career move? To apply, forward your application to the link provided or contact me on 087 0608656 OR [emailprotected]