Clinical Trial Assistant

Northreach is a dynamic recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation and professional growth.
We are partnered exclusively with a fast paced and growing Contract Research Organization (CRO) committed to advancing clinical research and contributing to the development of innovative healthcare solutions. The dedicated team of professionals work collaboratively to ensure the success of Clinical Trials and the delivery of high-quality results to clients.
THE ROLE: Clinical Trial Assistant
Key Responsibilities:
Trial Master File (TMF) Management:
Organize, maintain, and update physical and electronic Trial Master Files in accordance with regulatory requirements and company SOPs. Ensure the completeness and accuracy of TMF documentation throughout the lifecycle of the Clinical Trial. Electronic Trial Master File (eTMF) Migration:
Collaborate with cross-functional teams to facilitate the migration of TMF documents to the Electronic Trial Master File system. Implement and maintain eTMF processes and workflows in compliance with industry standards and guidelines. General Clinical Trial Support:
Provide administrative support to the Clinical Trial team, including coordinating meetings, preparing agendas, and maintaining trial-related documentation. Assist in the preparation and distribution of study-related materials, such as protocols, informed consent forms, and site communication. Quality Assurance:
Conduct regular quality checks to ensure the accuracy and completeness of TMF and eTMF documentation. Assist in internal and external audits, as required, and contribute to the implementation of corrective and preventive actions. Communication and Collaboration:
Collaborate effectively with internal teams, sponsors, clinical sites, and vendors to ensure smooth and efficient trial operations. Communicate regularly with study sites to collect and track essential documents, resolve queries, and provide support as needed. Qualifications:
Bachelor's degree in a relevant scientific or healthcare discipline. Previous experience in Clinical Trial administration or related roles is preferred. Familiarity with regulatory requirements, Good Clinical Practice (GCP), and ICH guidelines. Strong organizational and time-management skills with attention to detail. Excellent written and verbal communication skills. Proficiency in using electronic document management systems and Microsoft Office suite.
To apply, please submit your CV and please note all applications will be treated with the utmost confidentiality.
Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with businesses that promote DEI. We strive to create a welcoming and inclusive environment for all employees.