Clinical Trial Administrator

Role Overview

• Set up and maintains study specific databases.
• Set up and maintains clinical trial-related trackers such as regulatory documents and Trial Master File (TMF) in accordance with ICH GCP and study specific SOPs and as per Project Manager/Sponsor instructions.
• Develop strategies for ensuring complete and accurate delivery of research related data, management of studies and documentation.
• Archiving of paper and electronic data as required.
• Carry out regular quality control checks of trackers, ISF’s, site management information as required.
• Liaise with Clients and Vendors as required to fulfil role.
• Provide weekly reports on role specific tasks and progress against study deliverables.
• Support coordination of weekly reports and study metrics for internal and client review.
• To contact clinical sites for specific requests (e.g. enrolment updates, missing documentation, meeting arrangements, etc).
• To be familiar with ICH GCP, appropriate regulations, relevant NWEH SOPs and internal tracking systems.
• Ensure familiarity with risk issues pertaining to confidentiality of participant and research related documentation (General Data Protection Regulation 2018 and Caldicott Review 2013).
• Support and execute all activities in line with ISO standards where relevant (ISO 9001:2015).
• Work collaboratively with multiple stakeholders to ensure timely resolution of data queries.
• Ensure compliance with NWEH and local policies/guidelines and Standard Operating Procedures (SOPs) to ensure all procedures are followed correctly.
• Identify any study related issues or non-conformance and escalate within specified timelines.
• To assist the project teams with study specific documentation and guidelines as appropriate.
• To set up, organise and maintain clinical study documentation including preparation for quality control audits, internal/external audits, final reconciliation and archival.
• To attend project meetings.
• Perform other duties as assigned by management.

Requirements

• Research documentation management experience.
• Proficiency in Adobe Acrobat Professional (or similar) tools and web-based document indexing and viewing application.
• Computer skills including high level of proficiency in the use of Excel, PowerPoint and Microsoft Word.
• Good organisational skills, ability to manage multiple sites and meticulous attention to detail.
• Evidence of working and managing relationships within a Pharmaceutical or CRO company.
• Self-motivated, positive attitude with good oral, written communication and interpersonal skills.
• Flexible approach to working.
• Committed to self-development and able to demonstrate professional development.
• Ability to organise own work and meet deadlines.
• Willingness to work within a multi-disciplinary team, working autonomously and as a team player.
• Experience applicable to clinical research including clinical development phases and process including HRA and ethics regulatory processes.

Tech Stack

• Google Cloud Platform