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
Quality Engineer
Galway
Principal Quality Engineer
Galway
Clinical Trial Quality Representative
Cork
Process Validation Engineer
Cork
Project Manager - R&D
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Process Engineer
Cork
Technical Life Cycle & Engineering M
Galway
Recruitment Consultant
Republic of Ireland
Commissioning, Qualification and Valid
Carlow
Quality Validation Engineer
Limerick
Process Engineer (Shift)
Carlow
Project Engineer
Limerick
Suite Team Delivery Lead
Tipperary
Senior Validation Engineer
Dublin
QA Compliance Specialist
Carlow
Quality Specialist
Tipperary
Change Control SME
Cork
Senior Quality Engineer
Limerick
Senior Quality Engineer
Dublin
Senior Quality Engineer
Dublin
QC External Sample and Retain Coordinato
Carlow
R&D Manager
Dublin
Technology Transfer Specialist (Technica
Cork
Business Manager (Pharma Chemicals)
Westmeath
Validation Engineer
Carlow
Technical Transfer Specialist - Remote
Republic of Ireland
R&D Manager
Clare
Buyer
Wexford
Quality Manager - NPI
Dublin
Senior Manufacting Engineer
Republic of Ireland
Quality Control Technician
Carlow
Senior Recruitment Consultant
Republic of Ireland
Warehouse Manager
Dublin
Quality Manager
Dublin
Technical Specialist - Manufacturing Pro
Cork
Project Engineer
Roscommon
Manufacturing Engineer
Galway
R&D Engineer
Clare
Quality Control NPI Senior Associate
Dublin South
Project Manager
Limerick
Technical Sales Manager (Chemistry)
Westmeath
Biomedical Engineer
Dublin
Cleaning Validation Specialist
Cork
Commissioning and Qualification Engineer
Dublin
Manufacturing Technician
Clare
Senior R&D Project Manager
Galway
Project Engineer
Tipperary
R&D Senior Program Manager
Galway
Senior Human Factors Engineer
Dublin
Project Engineer - Senior
Cavan
Project/Process Engineer - Purification
Cork
Clinical Trial Quality Representative
Cork
Senior Project Manager - Electrical
Dublin
Project Manager - Capital Projects
Cork
Senior Quality Engineer
Dublin
R&D Manager
Athlone
QA Manager
Canada
Senior Recruitment Consultant
Republic of Ireland
Senior Equipment Engineer
Dublin
Technical Administrator
Tipperary
Senior R&D Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior Process Development Engineer
Galway
Mechanical Design Engineer
Germany
NPI Process Engineer
Carlow
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Senior R&D Manager/Director
Dublin
Project Manager
Galway
Global Safety Senior Manager
Dublin
Senior Process Engineer
Dublin
Quality Engineer
Galway
C&Q Lead
Tipperary
Operations Manager
Wexford
Manufacturing Engineer
Cork
Technical Transfer Engineer - Drug Subst
Louth
Project Engineer - Senior
Cavan
Senior Design Engineer
Dublin
R&D Engineer
Galway
R&D Technician II
Galway
Responsible Person (RP)
Republic of Ireland
Downstream Investigations Specialist
Dublin
Senior Design Assurance Engineer
Galway
Senior Supply Chain Manager
Wexford
R&D Director
Galway
Senior QC Associate
Dublin
Engineering Projects Lead
Carlow
Senior Project Engineer
Cavan
Senior Technical Transfer Specialist
Cork
Recruitment Consultant
Wexford
Chemical Engineer
Tipperary
Senior R&D Engineer
Galway
Account Manager UK and Ireland
Republic of Ireland
Product Development Manager
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Manufacturing Engineer
Wexford
Process Support Specialist
Carlow
Manufacturing Engineer
Galway
Technical Services Manager
Tipperary
Senior Process Engineer
Cork
Quality Specialist
Tipperary
Associate Director - Clinical Regulatory
Cork
Quality Engineer
Athlone
Quality Specialist
Clare
R&D Lifecycle Manager
Connaught
Senior Cleaning Validation Engineer
Carlow
Principal Device Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Principal R&D Engineer
Dublin
R&D Manager
Connaught
Senior R&D Engineer
Clare
Senior R&D Engineer
Galway
R&D Program Manager
Dublin
Compliance Engineer
Carlow
Operational Excellence Specialist
Meath
Senior R&D Engineer
Galway
Project Manager - R&D
Galway
R&D Manager
Galway
Strategic Automation Lead
Waterford
Quality Technician
Dublin
Electrical Engineer
Limerick
EHS Specialist
Carlow
Product Lead
Dublin
Quality Specialist
Clare
Quality Specialist
Dublin
Product Development Engineer
Galway
Senior Electronic Engineer
Dublin
Project Manager - R&D
Galway
Principal Engineer
Dublin
Senior Quality Engineer
Galway
Senior Microbiologist
Republic of Ireland
Clean Utilities Engineer
Cork
R&D Engineer
Galway
Microbiology Manager
Dublin
Principal Process Development Engineer
Galway
Scientist (hybrid)
Meath
Project Engineer
Republic of Ireland
Lead Maintenance Reliability Engineer
Westmeath
Principal Equipment Engineer
Dublin
Process Engineer
Limerick
Manufacturing Biotech Associate 24/7 Shi
Meath
Chief Medical Officer
Dublin
Sales/Customer Service Administrator
Clonmel
Project Manager - Suite Lead
Tipperary
Senior Project Engineer
Cork
Product Development Engineer
Dublin
Manufacturing Technician
Clare
Injection Moulding Engineer
Athlone
QA Manager
Canada
R&D Technician II
Galway
R&D Engineer
Galway
VP of Operations
Dublin
Injection Molding Engineer
North Leinster
Biostatistician
Dublin City Centre
Senior R&D Engineer
Dublin
Head of R&D
Galway
Senior Process Engineer
Cork
Software Design Assurance Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Quality Engineer
Wexford
Senior Associate Quality Control NPI
Dublin
Regional Program Coordinator - Global Le
Dublin
Maintenance Reliability Engineer
Cork
R&D Project Manager
Galway
Master Data Associate
Limerick
Senior R&D Engineer
Clare
Maintenance Planner
Westmeath
QC Instrumentation Engineer
Limerick
Injection Moulding Engineer
Athlone
Process Chemist
Limerick
R&D Manager
Connaught
Senior Operations Engineer
Galway
Manufacturing Engineer
Galway
R&D Engineer
Galway
QC Laboratory Technician
Carlow
Senior Regulatory Specialist
Cork
SAP Analyst - Logistics & Supply Cha
Limerick
Sourcing Specialist
Tipperary
Quality Assurance Engineer
Longford
Quality Engineer
Galway
Principal Engineer
Dublin
Senior Manufacturing Engineer
Cork
Associate Director Global Regulatory Aff
Cork
R&D Manager
Galway
Senior Equipment Design Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Dublin
R&D Manager
Connaught
Technical Specialist - Process Support
Cork
Senior Microbiologist
Dublin
Technical Transfer Lead
Dublin
Engineering Business Manager
Dublin
Quality Engineer
Athlone
Facilities Engineer
Carlow
Electrical Engineer
Cork
Process Engineer - Water Formulations
Limerick
Senior Microbiology Specialist - Greece
Republic of Ireland
Product Development Engineer
Dublin
R&D Engineer
Galway
Quality Operations Manager
Dublin
R&D Manager
Athlone
Senior Design Quality Engineer
Dublin
Senior Manufacturing Engineer
Galway
Senior Mechanical Engineer
Dublin
Project Process Engineer
Carlow
Senior R&D Manager
Athlone
R&D Manager
Galway
Senior HVAC Engineer
Dublin
R&D Manager
Athlone
Quality Control Technician
Carlow
R&D Director
Galway
Senior Project Engineer
Cavan
Quality Technical Services Manager - 12
Dublin
Senior R&D Engineer
Dublin
Senior Validation Engineer
Dublin
Quality Technician
Dublin
Chief Medical Officer
Dublin
Product Development Engineer
Galway
Senoior Specialist - MS&T
Dublin
Senior Electronic Engineer
Dublin
Procurement Senior Specialist
Meath
R&D Engineer
Galway
R&D Director
Galway
Senior Project Manager - Process Develop
Cork
QA Engineer
Leitrim
Senior Quality Engineer-Remote
Republic of Ireland
Principal Instrumentation Engineer
Limerick
R&D Engineer
Galway
Senior Project Engineer
Cavan
Senior Reg Affairs Specialist - Post Mar
Galway
Lead Chemistry Analyst
Cork
Change Control Coordinator
Carlow
Manufacturing Technician
Clare
Senior Electronics Engineer
Dublin
R&D Director
Galway
Quality Manager
Galway
R&D Manager
Galway
R&D Manager
Connaught
NPI Process Engineer
Carlow
CQV Lead
Tipperary
Principal R&D Engineer
Dublin
Production Operator
Carlow
Project Enginer
Dublin South
Senior Recruitment Consultant
Cork
Program Manager
Cork
Remote Process Engineer - Fill Finish
Republic of Ireland
Technical Specialist - Manufacturing Pro
Cork
Senior Operations Engineer
Galway
Electronic Design Engineer
Galway
Product Development Engineer II
Athlone
Product Development Manager
Galway
Senior R&D Engineer
Galway
Instrument Specialist
Tipperary
Senior Electronic Design Engineer
Dublin
R&D Engineer
Dublin
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]