Location: Liverpool
Department: Clinical Research
Hours: Bank
Salary: £46,648 per annum pro rata
Reports to: Director
Job Summary
We are looking for an experienced and dynamic Clinical Trials Site Manager to oversee the operational aspects of clinical trials at our site. The Site Manager will be responsible for the day-to-day management of clinical trials, ensuring they are conducted in compliance with all regulatory, ethical, and safety guidelines. The ideal candidate will have strong leadership skills, a keen eye for detail, and extensive knowledge of clinical trial processes.
This role is essential to the smooth functioning of the clinical trial process, from recruitment and screening of participants to data collection, patient safety, and regulatory compliance. As a Site Manager, you will ensure the highest standards of clinical care and safety are maintained throughout the trial lifecycle.
Key Responsibilities
Site Operations Management
- Oversee the day-to-day management of all aspects of clinical trial activities at the site, ensuring timely and effective execution of the protocol.
- Coordinate with sponsors, CROs, and internal teams to ensure smooth trial operations, including recruitment, data collection, and documentation.
- Act as the primary point of contact for trial-related activities and communications at the site.
- Ensure compliance with the clinical trial protocol, ICH-GCP guidelines, and regulatory requirements (e.g., MHRA, HRA, REC, FDA, EMA).
- Supervise the preparation and submission of regulatory documents, including informed consent forms, ethics committee approvals, and study-specific agreements.
Team Management & Leadership
- Lead and manage the clinical trials site team, including research nurses, clinical research coordinators, and administrative staff.
- Provide training and mentorship to junior staff on clinical trial protocols, procedures, and best practices.
- Ensure the team is well-supported, maintaining a positive and efficient working environment.
- Delegate responsibilities effectively, balancing workloads and ensuring adherence to timelines.
Patient Recruitment & Care
- Ensure the recruitment and retention of study participants in compliance with the trial’s inclusion/exclusion criteria.
- Oversee the informed consent process, ensuring patients are fully informed of the trial requirements and their rights.
- Coordinate patient visits, assessments, sample collections, and interventions in accordance with the clinical trial protocol.
- Monitor patient safety, adverse events (AEs), and serious adverse events (SAEs), reporting them according to regulatory requirements.
- Act as the point of contact for participant queries, providing clear communication and support throughout their involvement in the trial.
Compliance & Documentation
- Ensure accurate and timely completion of all study-related documentation, including case report forms (CRFs), patient records, and source documents.
- Monitor and maintain compliance with all regulatory and sponsor requirements, ensuring audits and inspections are passed with minimal findings.
- Coordinate and oversee the preparation for monitoring visits, audits, and inspections by sponsors, CROs, and regulatory bodies.
- Ensure proper storage, tracking, and archiving of trial documentation, ensuring data integrity and confidentiality.
Budget and Resource Management
- Assist in the preparation of trial budgets and ensure the efficient use of resources throughout the trial.
- Track and manage trial expenses, providing financial updates to the project manager or sponsor.
- Coordinate the ordering and inventory management of trial supplies, including investigational medicinal products (IMPs) and clinical trial materials.
Quality Assurance and Continuous Improvement
- Implement and maintain quality control measures to ensure the trial is conducted to the highest standards of quality and safety.
- Identify areas for improvement and work collaboratively to implement corrective actions where necessary.
- Stay up to date with the latest clinical trial trends, regulations, and best practices to enhance site operations.
Job Specification
Essential:
- Registered Adult Nurse with current NMC registration
- Minimum 3 years experience in clinical trials or clinical research
- Strong understanding of ICH-GCP, MHRA, HRA, REC guidelines, and trial-related regulations
- In-depth knowledge of clinical trial protocols, study designs, and patient care requirements
- Excellent leadership, team management, and communication skills
Desirable:
- Post-graduate qualification in clinical research or related field
- Previous experience as a Clinical Trials Site Manager
To apply for the position, please email hr@avrin.co.uk and and attach your CV
