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
Injection Molding Engineer
North Leinster
R&D Manager
Galway
Quality Specialist
Clare
Principal Engineer
Dublin
Project Manager - R&D
Galway
Project Engineer - Senior
Cavan
Change Control SME
Cork
Cleaning Validation Specialist
Cork
Head of R&D
Galway
R&D Director
Galway
Senior R&D Project Manager
Galway
R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Cleaning Validation Specialist
Cork
QA Manager
Canada
Senior Cleaning Validation Engineer
Carlow
Senior R&D Engineer
Dublin
VP of Operations
Dublin
Senior Electrical Engineer
Galway
Clinical Research Associate
Cork
Injection Molding Engineer
North Leinster
R&D Engineer
Galway
Program Manager
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Process Chemist
Limerick
Injection Moulding Engineer
Leitrim
Manufacturing Technician
Clare
Principal Process Development Engineer
Galway
Product Development Engineer
Dublin
Principal R&D Engineer
Dublin
Injection Molding Engineer
North Leinster
QC Laboratory Technician (shift)
Carlow
Senior Recruitment Consultant
Republic of Ireland
Downstream Investigations Specialist
Dublin
Material Handler
Carlow
Senior Regulatory Specialist
Cork
Advanced Technologies R&D Manager
Clare
Senior Validation Engineer
Carlow
Senior QC Associate
Dublin
Clinical Trial Quality Representative
Cork
Product Development Engineer
Dublin
Quality Manager
Dublin
R&D Engineer
Dublin
Manufacturing Engineer
Cork
R&D Director
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Injection Molding Engineer
North Leinster
Manufacturing Project Engineer
Mayo
Senior Design Assurance Engineer
Athlone
R&D Senior Program Manager
Galway
Senior Regulatory Affairs Specialist
Westmeath
Senior Manager Device Supplier Assurance
Dublin
R&D Manager
Athlone
Process Engineer
Galway
QC Laboratory Technician
Carlow
Production Operator
Meath
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Galway
Production Operator
Meath
R&D Manager
Athlone
R&D Manager
Connaught
Principal Process Equipment Engineer
Dublin South
Strategic Automation Lead
Waterford
Senior Process Development Engineer
Galway
Project Engineer
Limerick
Bioanalytical Senior Principal Scientist
Limerick
Product Development Engineer
Galway
Manufacturing Technician
Clare
Director of Quality Engineering
Limerick
Senior Quality Engineer
Leitrim
Staff R&D Engineer- Customer Focus
Dublin
R&D Manager
Connaught
Operations Manager
Wexford
R&D Manager
Connaught
MS&T Associate Director
Dublin
Senior Design Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Senior Process Development Scientist
Dublin
Senior Electronic Engineer
Dublin
R&D Director
Galway
Upstream Manufacturing Process Specialis
Cork
Principal R&D Engineer
Galway
R&D Manager
Galway
Quality Engineer
Athlone
Senior Associate Quality Control
Dublin
Senior Project Manager - Process Develop
Cork
Senior Quality Engineer-Remote
Republic of Ireland
Product Development Engineer II
Athlone
Quality Specialist
Clare
Manufacturing Technician
Clare
Senior Manufacting Engineer
Republic of Ireland
R&D Manager
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Clare
Senior Director Statistics Data and Anal
Cork
Sr. Associate - Quality for Computer Sys
Cork
Senior Equipment Design Engineer
Dublin
Senior QC Microbiology (24/7 Shift)
Dublin
Product Development Engineer II
Athlone
QA Engineer
Leitrim
Senior Operations Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Product Application Specialist (IVD) - I
Dublin
Compliance Specialist
Carlow
Principal Device Engineer
Dublin
Regulatory Affairs Associate
Cork
Quality Manager
Galway
Product Development Engineer
Galway
SAP Analyst - Logistics & Supply Cha
Limerick
Electronic Engineer
Dublin
Senior Design Assurance Engineer
Galway
Senior Equipment Engineer
Dublin
R&D Manager
Connaught
Technical Services Manager
Tipperary
Principal Scientist Device and Product P
Dublin
Project Engineer
Clare
Facilities Engineer
Carlow
R&D Engineer
Galway
Maintenance Reliability Engineer
Cork
R&D Manager
Galway
Senior R&D Engineer
Dublin
Quality Specialist
Tipperary
Senior Technical Transfer Specialist
Cork
Quality Technician
Dublin
Senior QA Associate (Shift)
Dublin
Quality Operations Manager
Dublin
Senior Mechanical Engineer
Dublin
Biostatistician
Dublin City Centre
Product Development Engineer
Dublin
Senior Associate QC
Dublin
R&D Director
Galway
Senior Quality Engineer
Leitrim
Senior Process Engineer
Dublin
Senior QC Microbiology (Shift)
Dublin
Process Engineer (NPI)
Carlow
QA Operations Specialist (hybrid)
Meath
Senior R&D Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Senior R&D Manager
Athlone
Product Development Engineer
Galway
Utilities Engineer - Black Utilities
Roscommon
Production Operator
Dublin
R&D Engineer
Galway
Principal Equipment Engineer
Dublin
Process Engineer (NPI)
Carlow
Quality Control NPI Senior Associate
Dublin South
Electronic Engineer
Dublin
R&D Manager
Galway
R&D Project Manager
Galway
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Embedded Software Engineer
Dublin
Project Manager - R&D
Galway
Associate Director - Global Core Labelin
Cork
Senior QC ELN Associate - Electronic Not
Dublin
Quality Systems Manager
Dublin
QC Separation Analyst
Cork
Responsible Person (RP)
Republic of Ireland
Senior Quality Engineer
Leitrim
Injection Moulding Engineer
Athlone
CTO
Dublin
Senior Regulatory Affairs Specialist
Athlone
Project Manager - R&D
Galway
R&D Engineer
Galway
Principal/Senior R&D Engineer Cathet
Galway
Account Manager UK and Ireland
Republic of Ireland
Clinical Research Associate
Cork
Senior Electronics Engineer
Dublin
Principal Software Engineer
Athlone
QA Operations Specialist (Shift)
Dublin
Mechanical Technician - 2 Cycle
Carlow
R&D Engineer
Galway
MS&T Scientist (Specialist)
Meath
Project Manager - R&D
Galway
Senior Design Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
R&D Engineer
Dublin
Manufacturing Engineer
Wexford
Quality Engineer
Galway
Senior Project Engineer
Cavan
Project/Process Engineer - Purification
Cork
R&D Engineer
Galway
Principal Process Development Engineer
Dublin
Project Manager Design Assurance
Galway
Manufacturing Engineer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
QA Manager
Canada
Associate Director Global Regulatory Aff
Cork
Senior Quality Engineer
Dublin
Quality Specialist
Tipperary
Cleaning Validation Specialist
Carlow
R&D Engineer
Galway
Manufacturing Engineer
Galway
Product Development Technician II
Galway
Quality Engineer
Athlone
Business Systems Director
Louth
Technical Administrator
Tipperary
Senior Process Engineer
Cork
Sourcing Specialist
Tipperary
Quality Engineer
Galway
Senior Research and Development Engineer
Galway
Sales/Customer Service Administrator
Clonmel
R&D Engineer
Galway
Lead Project Engineer
Carlow
(Senior) Manufacturing Engineers - Globa
Limerick
Clean Utilities Engineer
Carlow
Process Simulation Technical Engineer
Carlow
Senior R&D Engineer
Clare
Commisioning and Qualification Engineer
Cork
Project Manager - R&D
Galway
Senior Clinical Project Manager
Dublin
Senior Polymer Development Engineer
Galway
Quality Engineer
Galway
R&D Engineer
Galway
Product Development Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Quality Engineer
Wexford
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: Clinical Research Associate

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 [email protected]