Clinical Trial Administrator
Job Description: Clinical Trial Administration
Title: Clinical Trial Assistant
Position type: Permanent, Full time
Location: Flex; Office working in Wallingford (1-2 days per week) and home working
Reports to: Senior Project Manager
Role and responsibilities:
P1vital Products Ltd (PPL) is an established SME specialising in the development of mental health software products for the pharmaceutical and healthcare sectors. We have an excellent opportunity for a motivated individual with a keen interest in clinical research to progress their career as a Clinical Trial Assistant (CTA) within the medical device field. Reporting to the Senior Project Manager and working alongside the Clinical Research Associate (CRA), the CTA will be responsible for providing tailored administrative support to assigned projects. Key responsibilities of this role comprise:
• Familiarisation of study protocols and other relevant study documentation.
• Remain up to date with all relevant SOPs, ICH-GCP guidelines, and regulatory requirements, including demonstration of understanding of the ethical and/or regulatory requirements applicable to the studies assigned to.
• Assist the CRA in preparation for monitoring visits and visit reports if required.
• Assist the CRA in the resolution of quality issues, helping to ensure that issues are properly documented, tracked, and resolved in a timely manner.
• Assist with eCRF review, as requested i.e., query tracking, completeness checks.
• Coordinate project team meetings (both internal project team meetings, and external sponsor team meetings), and report details via minute taking, filing, and circulation.
• Conduct administrative tasks and other ad-hoc activities as required by the Clinical Research team and/or wider Project team.
• Set-up and maintain P1vital and Investigator Study Files/ eISFs.
• Create and maintain tracking tools for the study team.
• Perform reconciliation activities between trial management platforms/systems/trackers.
• Maintain the eTMF to a high standard, conducting reconciliation activities, and quality reviews as and when required.
• Coordinate the filing and archiving of all relevant documentation for the study to comply with relevant SOPs and regulations.
• Develop positive and constructive professional relationships.
Skills and experience:
• Graduate with life sciences or equivalent degree
• A strong interest in clinical research, and/or neuropsychiatry
• A minimum of 1 year’s prior CTA experience working in a clinical trials environment, preferable
• Knowledge of ICH-GCP guidelines, preferable
• Excellent communication skills (both written and oral)
• Ability to multi-task and problem solve
• A concern for quality, attention to detail and accuracy
• Good organisational and administrative skills
• Proficiency with MS Office applications, especially Excel
• Ability to work independently in a fast-paced environment
• Proactive contribution towards the team by being a flexible team player
To apply or find out more, please send your CV to email@example.com