We are currently partnering with a Galway based medical device start-up who are looking to hire a QA Clinical Trial Specialist as they expand.
As the QA Clinical Trial Specialist you will provide essential support to the clinical trial team in the planning, initiation, execution, and closeout of clinical trials. This position involves collaboration with cross-functional teams, ensuring adherence to regulatory standards, and contributing to the successful implementation of clinical trials. You will also provide QA, Compliance and Regulatory support to the team as required. This is a versatile role, working with a highly successful and exciting start-up and will provide excellent exposure and career progression.
- Assist in the selection and initiation of clinical trial sites.
- Coordinate the preparation and distribution of study documents to investigative sites.
- Provide QA, regulatory, EU MDR and quality system support to the management team as required.
- Support the maintenance of regulatory documents, ensuring compliance with applicable guidelines.
- Assist in preparing and submitting regulatory submissions as needed.
- Maintain and organize trial master files (TMFs) in compliance with regulatory requirements.
- Assist in data collection, analysis, and reporting activities.
- Ensure accurate and timely entry of study data into electronic systems.
- Assist in the coordination and communication with external vendors, surgeons and contract research organizations (CROs).
- Monitor vendor activities to ensure compliance with study protocols.
- Participate in quality assurance processes to ensure compliance with Good Clinical Practice (GCP) standards.
- Support internal and external audits as required.
- Assist in the preparation and review of study-related documentation, including clinical study reports.
- Ensure accurate and timely reporting of trial results.
- Bachelor's degree in a relevant discipline.
- Minimum of 3 years of experience in a clinical research or related role within medical devices
- Ability to travel up to 25%
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.