I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Colin Clare
Life Science

+353870608656
[email protected]
Connect with me on
Hot Science Jobs
Senior Regulatory Affairs Specialist
Athlone
Quality Assurance Specialist (Logistics)
Dublin
Manufacturing Engineer
Galway
R&D Senior Program Manager
Galway
Senior Quality Control Associate
Dublin South
Associate Analytical Scientist
Meath
Electronic Engineer
Dublin
Product Development Technician II
Galway
Principal R&D Engineer
Galway
R&D Manager
Galway
Senior R&D Engineer
Dublin
Production Operator
Carlow
Senior R&D Engineer
Galway
Manufacturing Engineer
Wexford
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Project Manager Design Assurance
Galway
R&D Engineer
Galway
R&D Director
Galway
Mechanical Technician - 2 Cycle
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Design Assurance Engineer
Athlone
Senior R&D Engineer
Dublin
R&D Manager
Athlone
R&D Engineer
Galway
Principal R&D Engineer
Dublin
Process Chemist
Limerick
R&D Engineer
Clare
Biostatistician
Dublin
R&D Manager
Connaught
Injection Moulding Engineer
Athlone
R&D Manager
Galway
Mechanical Technician
Carlow
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Product Development Engineer
Galway
Design Quality Engineer
Galway
Electronic Engineer
Dublin
Regulatory Associate
Cork
Senior Quality Engineer
Dublin
Quality Engineer
Galway
Purchasing & Planning Manager
Wexford
Sr Electrical Engineer
Galway
Principal Engineer
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
Application Software Engineer
Galway
Quality Manager - NPI
Dublin
Quality Engineer
Galway
Senior Process Development Engineer
Galway
R&D Project Manager
Galway
Validation Engineer
Athlone
Product Development Engineer
Dublin
Principal Engineer
Dublin
Senior Validation Engineer
Louth
Senior Quality Assurance Specialist (Shi
Dublin
Change Control SME
Cork
R&D Manager
Galway
R&D Director
Galway
Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior Associate Quality Control (Shift)
Dublin
Senior Recruitment Consultant
Republic of Ireland
Senior R&D Engineer
Galway
Quality Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior Design Assurance Engineer
Galway
Electronic Engineering
Dublin
Quality Assurance Specialist (hybrid)
Dublin
Senior R&D Engineer - Sustaining
Galway
Engineering Shift Technician
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Galway
Quality Engineer
Galway
Regulatory Affairs Associate
Cork
CTO
Dublin
Business Manager (Woundcare, Orthopaedic
Dublin
Quality Engineer
Athlone
Staff Systems Engineer
Limerick
Manufacturing Technician
Clare
Documentation Specialist
Louth
Product Development Engineer
Dublin
Quality Assurance Engineer
Longford
CTO
Galway
Product Development Engineer
Dublin
Engineering Support Specialist
Louth
Software Design Assurance Engineer
Dublin
Senior Quality Engineer
Dublin
R&D Manager
Galway
Design Assurance Engineer
Clare
Product Development Manager
Galway
Operations Engineer
Galway
Electronic Engineer
Dublin
Quality Assurance Team Lead
Cork
Senior Electronic Engineer
Dublin
Biomedical Engineer
Dublin
Associate Director - Manufacturing &
Limerick
Senior Equipment Engineer
Dublin
Senior Validation Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Product Development Engineer II
Athlone
Senior Quality Engineer
Galway
Technical Marketing Manager
Wexford
Lead Maintenance Technician
Kilkenny
Senior R&D Engineer
Dublin
Lead Chemistry Analyst
Cork
R&D Engineer
Galway
Site Microbiologist
Republic of Ireland
Quality Manager
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Principal Process Equipment Engineer
Dublin South
Senior Design Engineer
Dublin
R&D Engineer
Galway
Senior Design Engineer
Dublin
R&D Manager
Galway
Shift Technician (Injection Moulding)
Kildare
R&D Director
Galway
Project Manager (hybrid)
Dublin
Sr R&D Manager
Galway
Technical Life Cycle & Engineering M
Galway
Injection Moulding Engineer
Athlone
R&D Engineer
Dublin
Microbiology Manager
Dublin
Senior Electronic Engineer - Regulated M
Galway
Electronic Engineer
Dublin
Principal R&D Engineer
Galway
Project Manager
Kildare
Principal R&D Engineer
Galway
Clinical Research Associate
Cork
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Galway
Director of Regulatory Affairs
Galway
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Quality Engineer
Wexford
Warehouse Operator
Meath
Senior R&D Engineer
Galway
Design Assurance Program Manager
Galway
Utilities Engineer
Dublin
R&D Manager
Dublin
Documentation Specialist
Louth
Territory Manager (Woundcare)
Cork
Quality Engineer
Galway
Product Development Technician II
Galway
R&D Engineer
Galway
Mechanical Engineer
Dublin
R&D Manager
Connaught
Senior R&D Engineer
Galway
Maintenance CMMS Engineer
Tipperary
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Galway
R&D Manager
Athlone
Quality Specialist
Clare
Procurement Executive
Dublin
Senior Regulatory Affairs Specialist
Clare
Quality Specialist
Tipperary
R&D Engineer
Dublin
Product Development Engineer
Dublin
R&D Engineer
Galway
QA Manager
Canada
Cleaning Validation Specialist
Cork
Maintenance Reliability Engineer
Cork
Value Stream Team Leader / Production Su
Wexford
Manufacturing Engineer
Cork
Senior Research and Development Engineer
Galway
Design Assurance Engineer
Galway
Project Manager
Kildare
Senior Quality Engineer
Leitrim
Design Assurance Program Manager
Galway
Senior R&D Engineer
Dublin
Customer Services Manager (Pharmaceutica
Dublin
Production Manager
Dublin
Quality Technical Services Manager - 12
Dublin
Quality Assurance Senior Specialist
Louth
Quality Engineer
Galway
Engineering Support Specialist
Louth
Senior Reg Affairs Specialist - Post Mar
Galway
Principal Design and Development Enginee
Galway
Documentation Specialist
Louth
Senior cGxP Laboratory Technician
Dublin
Project Engineer
Limerick
Sr R&D Manager
Galway
R&D Engineer
Galway
Principal R&D Engineer
Galway
R&D Engineer
Galway
Product Development Manager
Galway
Senior Regulatory Affairs Specialist
Westmeath
Calibration Technician
Republic of Ireland
Injection Moulding Engineer
Leitrim
Senior Process Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
Senior Equipment Design Engineer
Dublin
Senior Recruitment Consultant
Dublin
Project Manager - R&D
Galway
Senior Microbiologist
Dublin
Senior R&D Engineer
Galway
Manufacturing Technician
Clare
Process Development Engineer
Galway
Operational Excellence Specialist
Cork
Responsible Person (RP)
Republic of Ireland
R&D Program Manager
Dublin
Embedded Software Engineer
Dublin
Product Development Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Connaught
R&D Manager
Connaught
Project Manager
Louth
Project Engineer
Roscommon
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Project Manager - R&D
Galway
Senior Engineering Manager
Limerick
Principal R&D Engineer
Galway
Quality Assurance Specialist (hybrid)
Dublin
Principal R&D Engineer
Galway
Senior Quality Engineer
Leitrim
QA Engineer
Leitrim
Product Development Engineer
Galway
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Clinical Research Associate


Reference:CCL (AHPD-441806) Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Associate Professor, Clinical Research Associate

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.

Responsibilities:
  • 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.
Required Education & Skills:
  • 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

Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0608656OR [email protected]