Clinical Research Physician
1 week ago
We are seeking a highly skilled and experienced Clinical Research Physician to join our team at Guy's and St Thomas' NHS Foundation Trust. As a key member of our Cardiorespiratory Clinical Research Facility (CRF), you will play a vital role in supporting the delivery of clinical studies in cardiac and respiratory medicine.
Key Responsibilities- Provide medical support for clinical studies in various therapeutic areas, including advanced therapies such as cell and gene therapies.
- Work closely with the CRF senior clinical team and nurse in charge to ensure the timely delivery of clinical studies to acceptable medical standards.
- Initiate strategies to anticipate and expertly manage medical safety issues, including emergencies.
- Support aspects of subject recruitment, including pre-study medical histories, informed consent, and medical examinations for ongoing studies.
- Provide medical cover outside of normal working hours, as determined by the nature of the studies being undertaken in the CRF.
- Accept delegated responsibility to ensure that assigned studies in the CRF are carried out safely and in compliance with the protocol.
- Be responsible for specific study-related medical decisions as agreed with the Study Principal Investigator.
- Perform clinical procedures as appropriate to the assigned study, including clinical examinations or testing, insertion of intravenous lines, and assessment of adverse events.
- Ensure that patients/volunteers in assigned studies give fully informed consent in writing before commencing a study.
- Evaluate and manage acute, sub-acute, and chronic adverse drug reactions and manage acute toxicological emergencies under the supervision of the consultants in charge.
- Assess and interpret safety and clinical data from assigned studies, including vital signs, ECGs, laboratory tests, and adverse events.
- Follow up and report adverse events as necessary.
- Communicate safety issues to the Principal Investigator for a study, the Head of Department or Designee, and report Serious Adverse Events to the study sponsor in accordance with Good Clinical Practice.
- Review study documentation and complete appropriate sections of Case Report Forms.
- Ensure that all clinical activities within the CRF are conducted in accordance with approved Standard Operating Procedures (SOPs).
- Participate in the writing and review of appropriate CRF SOPs in association with senior medical colleagues and CRF Quality Team.
- Maintain accurate and accessible research records and medical notes.
- Provide medical input into integrated clinical, safety, and statistical reports as requested.
- Contribute to the risk assessment and planning of risk mitigation strategies for early phase trials.
- Provide medical input and review of study protocols and other related study documentation and participate in research meetings, study review meetings, and meetings with principal investigators and study sponsors.
- Maintain awareness and keep abreast of latest technologies in the medical field and share that knowledge with the Quintiles Drug Research Unit clinical team and CRF team.
- Prepare reports for submission to pharmaceutical companies, regulatory bodies, and medical and scientific journals as appropriate.
- Ensure personal Trust mandatory training is up to date and support the training of medical, nursing, and ancillary staff as required.
- Assist with business development activities as appropriate, including the development and maintenance of professional relationships with local opinion leaders and other GSTT/KCL departments.
- Develop and maintain computer skills to utilize available systems for the efficient management and administration of the day-to-day activities of the CRF.
- MBBS or equivalent medical qualification.
- MRCP or equivalent.
- Good Clinical Practice (GCP).
- Advanced Life Support ALS.
- Evidence of achievement of foundation and IMT competencies or equivalent.
- Good clinical care and maintenance of good medical practice.
- Good relationships with colleagues and patients.
- Professional behavior and probity.
- Previous experience within respiratory medicine.
- Audit.
- Teaching and research ability.
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