Clinical Trial Assistant

About Atlantia Clinical Trials

Atlantia Clinical Trials Ltd is a premier contract research organization (CRO) globally recognized for its specialization in conducting human clinical trials. We serve medical device, nutraceutical, and cosmetic industries across the United States, Europe, and the Asia-Pacific region. Our operations are enhanced by in-house research facilities in Ireland and the USA, enabling us to manage study initiation and execution efficiently without external outsourcing. Our core competencies include conducting investigations aligned with FDA and EU MDR regulations, performing usability and performance trials for devices, efficacy studies for nutraceuticals, and research in areas like the microbiome. Atlantia is committed to assisting clients in gathering robust clinical evidence essential for regulatory approvals, successful product launches, and sustained market expansion through meticulously designed and scientifically sound clinical programs.

Role Description

This role involves providing crucial support to the Project Manager and the wider clinical research team. Key responsibilities include assisting with the initial setup of studies, preparing essential documentation and participant kits, and participating in internal site initiation visits. The successful candidate will attend study-specific training to gain a thorough understanding of all required assessments and procedures. A significant part of the role will be to aid the Recruitment Officer in identifying, engaging, and screening potential participants for clinical trials. Data management is also a core function, requiring accurate entry into electronic case report forms (eCRFs) following established work instructions and Standard Operating Procedures (SOPs), along with performing quality checks on entered data. The position also entails supporting the laboratory team with the processing and proper storage of biological samples, advising participants on completing dietary records, and analyzing these records using specialized nutritional software. Maintaining accurate logs for investigational products and participant screenings is essential. Effective communication with the Project Manager regarding completed tasks and any emerging issues is vital. The role also includes the processing and dispatch/storage of samples as dictated by study protocols. Other duties as assigned will also be part of the role.

Required Qualifications and Experience

• Possession of a Bachelor's or Master's degree in Nutrition, Public Health, or a closely related health or science discipline.
• Proficiency in IT, including experience with booking systems and the Microsoft Office suite.
• A willingness to adapt to the working week, as early morning and evening work may occasionally be necessary.
• Exceptional interpersonal, organizational, and communication abilities.
• A keen eye for detail, coupled with a strong commitment to participant well-being and adherence to regulatory standards.

Desirable Skills

• Prior experience within a CRO, research setting, or clinical study environment.
• Familiarity with Good Clinical Practice (GCP) principles.
• The capacity to work effectively as part of a multidisciplinary team.

Additional Information

A flexible approach to the working week is required, as early mornings and evening work may be necessary.