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    Senior / Clinical Research Physician - Leeds, United Kingdom - Pharmiweb

    Pharmiweb
    Pharmiweb Leeds, United Kingdom

    2 weeks ago

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    Description

    Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases.

    With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives.

    We are looking for a Research Physician to join our Medical - Clinical Pharmacology Department where you will medically screen all healthy volunteers who want to participate in Clinical Trials at Simbec-Orion's Clinical Pharmacology Unit and provide ongoing medical support for all trials undertaken by Simbec-Orion by reviewing ECGs, vital signs, blood results and adverse events.

    In addition, you will act as a Principal Investigator on assigned studies, ensuring that all procedures performed are to acceptable Medical, Scientific and Ethical Standards and, that all trials are run according to protocols standard operating procedures (SOPs), and that they meet all regulatory requirements and ICH-GCP.

    Perform medical screening for potential participants to ensure they meet the medical requirements of the study.

    Perform ongoing monitoring and post-study clinical examinations (review of ECGs, vital signs, blood results and adverse events) and clinical procedures as appropriate to each study (cannulation, dosing procedures, nasogastric tubes, skin biopsy samples etc.).

    Report any clinically significant abnormal results and/or changes from baseline and action taken to the designated Study Principal Investigator, Medical Director and/or Sponsors.

    Evaluate participant's eligibility for inclusion in a specific study according to the information contained in the Investigator Brochure, Protocol and Informed Consent Document.

    Monitor, assess and record any adverse events and decide on the medical management of clinically significant events in conjunction with the Sponsor, Principal Investigator and/or Study Physician.

    Review study protocols and participant information sheets to ensure they meet regulatory and ICH-GCP requirements.
    Prepare Safety Data for reports and present at Safety Review meetings with the client.
    Prepare study-specific training and training slides and deliver training to wider Medical, Clinical and Enrolment Services departments.

    Be proficient in the procedures of Advance Life Support and to be capable of dealing with acute medical emergencies that may arise in the Clinic Pharmacology Unit.

    Provide medical cover outside of normal working hours as part of an On-Call Rota.

    Medical Degree.
    2 years clinical experience post-Foundation (or equivalent) in approved training posts
    Member of a suitable medical defence organisation (e.g. Previous experience working within a Clinical Research Environment
    Experience of managing participant safety (eligibility, ongoing review/assessment) and management of Medical Emergencies.
    Competent in MS Office Packages
    Post-graduate Qualification in Clinical Pharmacology
    Previous Clinical Trial and/CRO/ Bio-Tech /Pharma Experience
    Experience and understanding of requirements for a Phase I MHRA Accredited Unit
    Experience with Clinical Trial Management Systems (CTMS)
    Experience in leading cross-functional project/clinical teams
    Risk identification/management; Competent in using Data Capturing Systems

    Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

    So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services.

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