Location: Liverpool
Department: Clinical Research
Hours: Bank
Salary: 65,000 per annum pro rata
Reports to: Director
Job Summary
We are seeking a highly skilled and motivated Clinical Trials Physician to join our clinical research team. The post holder will be responsible for the medical oversight of clinical trials, ensuring the safety and wellbeing of study participants, and ensuring that clinical trial activities are conducted in line with Good Clinical Practice (GCP), relevant regulations, and the trial protocol.
The ideal candidate will have a background in clinical practice, with experience in managing patients and overseeing clinical trial protocols. You will work closely with the research team, including clinical research coordinators, nurses, and investigators, to ensure the smooth running of clinical studies and compliance with ethical and regulatory standards.
Key Responsibilities
- Clinical Oversight & Patient Management
- Provide medical oversight for participants in clinical trials, including screening, recruitment, and monitoring of patient safety.
- Perform clinical assessments, including physical exams, laboratory tests, and diagnostic evaluations, to determine patient eligibility for clinical trials.
- Ensure informed consent is obtained from participants, explaining study procedures, risks, and potential benefits.
- Monitor adverse events (AEs) and serious adverse events (SAEs) in accordance with trial protocols, reporting as necessary to the sponsor, regulatory bodies, and ethics committees.
- Act as the medical lead in addressing any patient-related clinical concerns, complications, or deviations from the protocol, ensuring prompt intervention if necessary.
Clinical Trial Management & Compliance
- Collaborate with the principal investigator and clinical trials team to ensure the trial is executed in accordance with ICH-GCP, local regulatory requirements (e.g., MHRA, FDA), and the study protocol.
- Ensure accurate and timely documentation of clinical data, including patient records, adverse events, and trial-specific case report forms (CRFs).
- Review and ensure the completeness and accuracy of clinical data before submission to sponsors or regulatory bodies.
- Participate in study team meetings, providing clinical expertise and feedback on study design, protocol amendments, and patient recruitment strategies.
- Oversee the preparation and submission of regulatory documents, including ethics committee approvals and reports to regulatory authorities.
Quality Assurance & Audit Support
- Participate in clinical trial audits and inspections, providing clinical insight and supporting the resolution of any findings.
- Ensure that all medical records, participant data, and trial documentation are maintained according to GCP guidelines, data protection regulations, and sponsor requirements.
- Support and collaborate with quality assurance (QA) teams to ensure compliance with trial protocols and regulatory standards.
- Identify and report any discrepancies, protocol deviations, or non-compliance issues, working with the team to implement corrective actions.
Training & Education
- Provide training and guidance to other clinical staff (e.g., research nurses, coordinators) on clinical trial protocols, patient safety procedures, and best practices.
- Stay up to date with developments in clinical research, therapeutic areas, and regulatory guidelines.
- Contribute to the development of standard operating procedures (SOPs) and clinical trial training materials.
Collaboration & Communication
- Liaise with the sponsor, CRO, and other external stakeholders to ensure effective communication throughout the trial lifecycle.
- Work collaboratively with multidisciplinary teams, including statisticians, pharmacovigilance teams, and regulatory bodies, to ensure the smooth operation of the trial.
- Provide medical input to participant recruitment strategies, ensuring the selection of appropriate patient cohorts for the trial.
Job Specification
Essential:
- Medical degree (MBBS, or equivalent) with full registration with the GMC
- Minimum of 3 years post-registration clinical experience in a healthcare setting
- Experience in patient management, clinical assessments, and documentation
- Good knowledge of ICH-GCP, MHRA, HRA and REC guidelines
- Strong understanding of patient safety protocols, adverse event reporting, and risk management
- Excellent communication and interpersonal skills, able to explain complex medical information to patients and colleagues
- Strong organisational and time management skills with the ability to multitask
- Ability to maintain accurate clinical records and adhere to strict regulatory and confidentiality standards
- High attention to detail and a commitment to patient safety and quality care
Desirable:
- Post-graduate qualification in clinical research or related field
- Experience working in clinical trials, research, or regulatory environments
- Experience in clinical trial protocol development or medical monitoring
- Experience with clinical trial data analysis and interpretation
- Training and management experience of junior staff
- Proficiency with clinical data management and electronic health records (HER)
- Research or publications in clinical trials or related medical fields
To apply for the position, please email hr@avrin.co.uk and and attach your CV
