Job Description
Bodyline Medical Wellness Clinics is a leading CQC-registered clinical services and clinical research group with nearly 20 years of experience delivering patient-centred, medically supported health programmes. With seven clinics across the Northwest and a nationwide telehealth service, Bodyline specialises in obesity, metabolic and female health — offering GLP-1 weight management, hormone replacement therapy, and diagnostic health services.
As part of our continued growth and commitment to innovation, accessibility and improved health outcomes across the UK, Bodyline has expanded through a dedicated Clinical Research Trial Services and is recruiting a Senior Clinical Trial Assistant. As the successful role-holder you would be responsible for providing advanced study administration, regulatory, and data management support across multiple clinical trials while acting as a mentor and subject matter expert for Clinical Trial Assistants.
You will be responsible for ensuring high-quality study documentation, regulatory compliance, timely data entry, and query resolution. The role serves as a key operational link between investigators, research nurses, CRCs, sponsors, CROs, and site management.
You will be reporting to the Lead Clinical Trial Assistant & Head of Clinical Research Operations & Business Development.
Key Responsibilities
Data Management
- Oversee data entry activities across assigned studies.
- Ensure data is entered accurately and within sponsor timelines.
- Monitor study query reports and coordinate timely resolution.
- Conduct quality checks of EDC entries completed by CTAs.
- Support reconciliation of source documents and EDC systems.
- Produce study data performance reports.
Regulatory & Essential Document Management
- Maintain study regulatory documentation across multiple trials.
- Perform quality reviews of ISF and regulatory files.
- Ensure all essential documents remain inspection-ready.
- Track and manage document renewals and expiries.
- Support ethics submissions and study amendments.
- Coordinate collection of investigator and staff documentation.
ISF & TMF Oversight
- Conduct routine ISF quality reviews.
- Support TMF reconciliation activities.
- Identify and correct filing deficiencies.
- Ensure documentation is filed within required timelines.
- Prepare study files for monitoring visits, audits, and inspections.
Study Coordinator Support
- Support study start-up, maintenance, and close-out activities.
- Coordinate study trackers and operational reports.
- Assist with study feasibility and site activation documentation.
- Support visit scheduling and study logistics.
Mentorship & Training
- Provide day-to-day support to CTAs.
- Train new CTA team members.
- Assist with onboarding activities.
- Promote consistency across sites.
- Share best practices and process improvements.
Quality & Compliance
- Support CAPA implementation.
- Participate in internal audits.
- Ensure compliance with ICH-GCP, MHRA regulations, SOPs, and GDPR requirements.
Key Performance Indicators
- Data entry completed within sponsor timelines.
- Query resolution within 3 working days.
- ISF quality score ≥98%.
- Zero critical regulatory findings.
- Successful onboarding and mentoring of CTA staff.
- Audit and inspection readiness maintained.
Qualifications and Experience
Essential
- Minimum 2–3 years clinical research experience.
- Experience with EDC systems.
- Experience maintaining ISF and regulatory documentation.
- Strong understanding of ICH-GCP.
- Excellent organisational and communication skills.
Desirable
- Previous CTA, CRC, or Regulatory Coordinator experience.
- Experience supporting audits and inspections.
- Experience mentoring staff.
Skills & Competencies
- Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
- Experience managing ISF/eISF, essential documents, and study start-up, maintenance, and close-out activities.
- Excellent organisational skills with the ability to manage multiple studies and priorities.
- Strong leadership, mentoring, and team development capabilities.
- High attention to detail with a commitment to quality and compliance.
- Effective communication and stakeholder management skills.
- Proficiency in Microsoft Office and clinical trial systems (eTMF, CTMS, EDC).
- Ability to identify risks, solve problems, and drive operational excellence.
- Ability to work independently, take ownership, and deliver to deadlines.
- Commitment to continuous improvement, audit readiness, and regulatory compliance.
