Study Start Up Associate I
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Job Description
IVD Study Start-Up Associate facilitating site activation and regulatory submission activities in clinical studies. Collaborating with teams to ensure compliance with regulations and timelines.
Responsibilities:
- Preparing, compiling, and submitting regulatory and ethics documentation, including clinical trial applications and ethics committee submissions
- Coordinating with internal teams, sponsors, regulatory authorities, and investigative sites to secure required approvals and authorisations for study initiation
- Maintaining accurate and inspection-ready records of regulatory submissions, approvals, and essential study documents
- Supporting study teams in the development, review, and management of key study documentation, including protocols, informed consent forms, and investigator brochures
- Participating in study start-up meetings, providing guidance on regulatory requirements, timelines, and activation strategies
- Tracking study start-up milestones and proactively identifying and resolving issues that may impact activation timelines
- Ensuring all activities are conducted in accordance with applicable regulations, ICH-GCP guidelines, and company SOPs
Requirements:
- Bachelor's degree in Life Sciences or a related scientific discipline
- Previous experience in clinical research, study start-up, regulatory affairs, or site activation within a CRO, sponsor, or healthcare environment
- Hands-on experience preparing and coordinating UK clinical study submissions
- Knowledge of applicable regulatory requirements and clinical research processes
- Strong organisational skills with the ability to manage multiple priorities and timelines
- Excellent communication and stakeholder management skills
- Experience in In Vitro Diagnostics (IVD) studies is highly desirable
- Willingness to travel within the UK occasionally, approximately 5%
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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