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RDL Scientific Limited

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Job Details
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Clinical Trial Physician

Business Type: Clinical Research Organisation
Job Type: Clinical Physician
Job Level: Experienced (non manager)
Position: Full Time
Salary: £60-65k
Location: Cambridgeshire
Reference: CTP
Job Details:

The Clinical Unit Cambridge (CUC) Clinical Trials Physician works alongside the multidisciplinary research team at the CUC to deliver high quality clinical care during the conduct of clinical trials of investigational medicinal product/s and experimental medicine studies. They have specific responsibilities for the management and coordination of clinical studies and safety governance for clinical research conducted at the CUC.

This CUC Clinical Trials Physician requires competent IT and excellent interpersonal skills.  Working with central company teams on early clinical development and translational medicine. The role will suit someone willing to work flexibly including some evening work if needed to cover e.g. 1 – 9pm shifts.

The Role Includes:

·       Working collaboratively with the CUC staff and central company team members to ensure delivery of high quality and safe clinical trials in healthy volunteer and patient populations.

·       Building effective networks, within and outside the company and working closely with members of the central company team, to provide CUC expertise into the medical and scientific aspects of study plans and protocol.

·       Act as co-Investigator or Principal Investigator (PI) (with the exception of First-Time-in-Human [FTIH]) on clinical studies, including and not limited to clinical pharmacology studies and experimental medicine studies.

·       Responsible for protocol-related activities, including (but not limited to) supporting participant recruitment, obtaining informed consent, medical screening, performing ongoing monitoring and post-study clinical examinations, review and interpretation of vital sign, ECG, spirometry, Holter and laboratory test results.

·       Responsible for study specific and diagnostic/therapeutic procedures, e.g. venepuncture, cannulation, suction blisters, punch biopsies, ECGs and assist with their processing.

·       Responsible for providing flexible support for clinical activities on an as needed basis.

·       Responsible for dosing and/or provides oversight of dosing (e.g. when undertaken by nursing staff, Physician Associates) of study medication including investigational medicinal products (IMPs) and non-IMPs, through all routes of administration, e.g. oral, intravenous, subcutaneous.

·       Provides complete medical cover (in conjunction with the other physicians) for recruitment of volunteers and patients, during study conduct, and study follow-up.  This includes coordination and provision of medical cover outside normal working hours as defined by the study protocol or Medical Director/Associate Medical Director, or as deemed appropriate in an emergency.

·       Provision of on-callout of hours cover, on a rota basis, in conjunction with the other physicians.

·       Responsible for medical safety and governance decisions, and escalating these to the Principal Investigator, Associate Medical Director/Medical Director, Medical Monitor, where appropriate.

·       Develops strategies to anticipate and expertly manage medical safety issues, including emergencies.

·       Ensures compliance with acceptable medical standards and the requirements of the protocol, standard operating procedures, ICH GCP, Research Ethics Committees (RECs), regulatory authorities and other applicable guidelines and regulations.

·       Maintains accurate research records and notes (source documentation), with data entry into paper or electronic databases as required.

·       Maintains knowledge and proficiency in medical practices (e.g. ALS certification), through continued professional development, and aiding the development of the multi-disciplinary staff at the CUC through teaching/training/supervision where appropriate.

·       Contribute to and maintain standards, to ensure the delivery of high quality and safe clinical trial conduct at the CUC, through relevant audit and quality improvement and governance activities

·       Accountable for authoring (where required) and reviewing and approving the Informed Consent Form (ICF) and relevant REC submission documentation.

·       Accountable for responding to questions from RECs, and regulatory authorities as required.

Education requirements and experience:

·       Full registration with UK General Medical Council with a licence to practise.

·       MBBS or equivalent.

·       UK trained doctors: at a minimum, will have completed their early Specialty or General Practice training (Postgraduate Membership of a Royal College is desirable) and have relevant acute medicine experience.

·      Doctors who have trained outside of the UK, will be able to demonstrate equivalent qualifications and experience of clinical practice in acute care of patients.

·       Experience in clinical pharmacology in early phase I/II studies, commercial or academic is desirable.

·       A relevant post-graduate qualification in clinical pharmacology or pharmaceutical medicine is desirable. It is expected that work will be undertaken in this role, towards qualification for becoming a first time in human principal investigator.

·       Commitment to train toward and/or the Advanced Life Support Provider (as a minimum)qualification of the UK Resuscitation Council (UK).

·       Strong verbal and written communication skills

·       Excellent interpersonal skills and energy to operate in a complex organisation environment

·       Ability to maintain and develop relationships and networks with different communities

RDL Scientific Limited Posted by:: RDL Scientific Limited (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 20/06/2022 | NPJ Ref: 309849
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