Clinical Research Physician​/Clinical Rater

Overview

The post holder will provide medical care and oversight of clinical trial participants, assisting the Principal Investigator to ensure safe, compliant and high-quality study delivery. The role requires collaboration with the trial team to ensure efficient conduct and safety monitoring of study processes in accordance with ICH-GCP.

The post holder will be a flexible, motivated team leader with expertise in conducting and overseeing clinical trial delivery and familiarity with the legislation relevant to running clinical trials. The work requires initiative, accuracy, attention to detail, and excellent time management. Communication will be with clinical staff, the public, and research sponsors (and CROs). The post holder will represent ACR. All work will be carried out in accordance with the EU Directive, ICH-GCP, Research Governance and local Standard Operating Procedures and Policies.

On-site work at ACR and conduct of trial-related procedures are expected.

Research Governance

• Responsible for conducting clinical trials according to the approved clinical trial protocol
• Adheres to Good Clinical Practice guidelines and principles in the conduct of research and in leading the trial delivery team
• Provides oversight for the overall conduct of the clinical trial with clearly documented evidence
• Complies with the relevant laws, regulations, ethics guidelines, and institutional policies related to responsible clinical trial conduct
• Ensures appropriate approvals are obtained before the commencement of the trial, and that conditions of any approvals are adhered to during the trial
• Delegated to receive informed consent from trial participants adherent to ICH-GCP guidelines and GDPR
• Advocates and ensures the appropriate process for receiving informed consent from trial participants and its documentation across the team
• Ensures participants’ welfare during the clinical trial
• Provides necessary medical care to study participants required due to adverse events experienced during or following the study that are related to the study
• Informs the participant's primary clinician about the participant's involvement in the study
• Supports the PI in providing timely reports to the trial sponsor mandated by MHRA on all significant safety issues (SUSAR, AESI, SAE) and information that might affect ethical and scientific acceptability of the study
• Ensures timely and accurate adaptation and execution of approved amendments by the trial delivery team and disseminates follow-through communication of changes to clinicians and participants as warranted
• Ensures necessary re-consenting of trial participants is done in a timely fashion and in accordance with protocol and GCP guidelines
• Discloses and manages actual, potential, or perceived conflicts of interest
• Responsible for ongoing consent
• Responsible for establishing trial participants' level of compliance and documenting reasons for withdrawal with communication to the Sponsor
• Retains clear, accurate, secure, and complete records of all clinical trial documentation, including clinical trial data and primary materials
• Complies with regulatory requirements related to reporting of unexpected serious adverse drug reactions to the regulatory authority and Sponsor/CRO as required by the approved protocol
• supervises and works with the Site Study Coordinator/Research Nurse
• Attends study investigator meetings, monitoring appointments, and site data reviews
• Timely review of clinical data and sign-off of electronic data records

Leadership and Professional Development

• Provides mentorship and supervision for the responsible delivery of clinical trials to other clinicians and research staff
• Promotes education and training in responsible clinical trial conduct

Clinical Excellence

• Regularly assesses ongoing safety of participants during trial involvement and raises concerns promptly to the PI and clinical team for risk assessment and evaluation
• Responsible for prescribing emergency and supplemental medications required during the conduct of the trial
• Performs medical procedures such as physical exams, medication reviews, diagnostic reviews and confirmation, psychometric assessments, clinical rating assessments, eligibility confirmation, and review of participants  fitness for discharge
• Regularly attends discussions/meetings relevant to patient safety, quality, and key metric improvements
• Conducts clinical and auxiliary procedures according to protocol as warranted for participant well-being and safety

Requirements

Personal Profile

• Knowledge and
  
  Experience:
  
  General Medical Council full registration to practice
• Evidence of post-registration clinical experience
• Previous research experience as Sub/I or PI leading a study
• Experience in conducting psychometric (including MINI, MADRS, GAD7, CGI-S and C-SSRS) and neurological assessments
• GMC Registration with full license to practice
• Willingness to mentor and train junior research physicians as part of the Learning and Development Programme
• Articulate and…