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Senior Clinical Research Associate

2 months ago

Dublin, Dublin City, Ireland Cpl Full time

On behalf of our client, a medical technology company, we are currently recruiting for a Senior Clinical Research Associate. This is hybrid role with a Dublin based company. The role reports to the Director of Clinical Research.

Position Overview

The company are now seeking to expand our clinical research team to work on various elements of clinical research projects but to primarily assist on the initiation and execution of a variety of research projects. This role reports directly to the Director of Clinical Research to coordinate and manage tasks but will also work closely with the Scientific Communications Manager. You will work with clinical research and clinical affairs teams to fully understand the patient journey, internal processes and data available in order to create the appropriate material for each research project. You should be comfortable with the full research project cycle from initiation to close-out, where you will be required to create clinical documentation required as part of ethics submissions and see through the completion of research projects in line with the required regulation of a region (ISO 14155, MDR, FDA etc.). You should also be familiar with the process for disemination of results from research projects through either peer-reviewed journal articles, trade journals or conference abstracts for example.

Position Responsibilities and Essential Functions

· Develop or coordinate development and approval of study documentation such as the study protocol, ICF, study-specific guidelines, regulatory documents, monitoring, data management and statistical analysis plans and clinical study report, in accordance with internal SOPs and GCP requirements.

· Define and drive study/project timelines and milestones.

· Contribute to the development of regulatory documents, responses to Health Authority/Competent Authority and EC/IRB questions.

· Conduct monitoring activities to ensure data quality.

· Ensure study team members are timely informed, trained and updated on their role and responsibilities through-out the duration of the study.

· Liaise and coordinate with external study vendors, where applicable, for certain research projects.

· Ensure that the team are regularly updated on research project/study progress, challenges and risks through-out the duration of the projects.

· Work cross-functionally, in particular with the clinical affairs team on MDR related documentation requiring input from the research team such as the Clinical Development Plan, PMCF Plan and Report.

· Oversee database lock activities to ensure timely data availability and coordinate study close out as needed.

· Contribute to and work with the Scientific Communications team to disseminate results from research projects in peer-reviewed and trade journals.

Education, Qualifications and Experience:

A PhD or Master's Degree in life science, psychology, medical science, or biomedical engineering or equivalent industry experience in clinical research associate/medical writing roles.

Required:

· 3+ years of research experience in the healthcare or medical device industries or in a post-doctoral position.

· Broad & in-depth expertise in clinical operations and regulations.

· Exceptional technical writing skills.

· Experience in executing a wide range of clinical trial activities (from initiation to clinical study report)

· Experience selecting and managing external service providers

· Strong attention to detail and commitment to quality.

· Demonstrated expertise in global clinical research & development and project management (including risk management and contingency planning)

· A team player with excellent interpersonal and communications skills, with the ability to solve problems ad-hoc.

· Great attention to detail.

Preferred:

· Relevant experience in the tinnitus, audiology, pain or neuromodulation fields.

· Good understanding of research design methodology.

· Experience publishing in peer-review scientific journals and with the review process.

· Self-motivation so you can work with limited supervision.

· Experience in managing multiple content and studies at different stages.

For full details contact Linda at or email your CV to Thornshaw Scientific is a division of the CPL Group