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Keywords
Description
Responsibilities of Screening Physician or Bank Screening Physician
- Being familiar and complying with Good Clinical Practice (GCP), EU Directive /EC, Statutory Instrument 2004 No. 1031 and current amendments
- Being familiar with study protocols, information and consent forms, and the inclusion and exclusion criteria for each study, before screening any volunteer subjects
- Being familiar with the standard operating procedures relating to screening
- Assisting the administration and recruitment teams in design of advertisements for volunteer subjects
- Briefing the recruitment and screening team on medical aspects of studies
- Answering telephone queries from volunteers, as necessary, with the aim of establishing their suitability for studies
- Checking that volunteer subjects have understood the information and consent form; explaining the elements of the studies and the risk of discomfort or injury; and obtaining written consent
- Medical history and examination of subjects, as required by protocol and HMR Standard Operating Procedures
- Assisting and guiding the screening team in the collection of biological samples
- Explaining to volunteer subjects the significance of any abnormal findings in history, examination or investigations
- Contacting the volunteer subject's personal physician as necessary, to discuss possible medical contraindications to study participation
- Maintaining compliance with guidelines for Good Clinical Practice, and with the ethical principles of the Declaration of Helsinki.
- Creation and maintenance of standard operating procedures relevant to the screening process
- Participation in meetings of physicians, and other company meetings if appropriate, as the screening schedule allows
- Ensuring confidentiality of clinical information about subjects, and of information provided by sponsors
- Assisting the Medical Director in the maintenance of high standards of performance among nursing and technical staff
- Helping to maintain cleanliness and tidiness of clinical and office areas
- Responding to issues raised by the Quality Manager
- Keeping personal training record up to date
- Participation in the company's appraisal process
