This position exists to provide physician cover for Covance Clinical Research Unit (CRU) Leeds. The locum may provide physician cover for the screening department i.e. perform screening physical examinations, obtain informed consent and perform clinical assessments on healthy volunteers and patients who may be selected for taking part in Phase I and II clinical trials.
A. Duties and Responsibilities:
Screening Physician Role:
* Perform physical examinations on research volunteers and patients during the screening process to assess that they are fit and healthy for intended clinical studies.
* Perform other clinical examinations and measurements when specified by a protocol.
* Maintain full clinical records of all findings.
* Ensure that each volunteer has received an explanation of the nature, purpose and possible risks of an intended study, and has been given the opportunity to ask questions on any relevant aspects of the project, prior to obtaining informed consent for taking part in clinical studies.
* Perform all elements of the job to the highest possible standards of quality, maintaining all documentation to Good Clinical Practice standards.
* Review GP Reports to ensure volunteers are eligible for participation in healthy volunteer studies.
* Interpret screening laboratory data, special investigation reports (eg. Holters) to determine eligibility of volunteers for clinical trials.
* Review the Screening CRF and determine the eligibility of the volunteer for participation in the study.
* Maintain communication with the volunteer and/or GP when previously undiagnosed conditions have been detected.
* Discuss volunteer suitability for a study with the Sub-Investigator or Principal Investigator.
* Must have full registration with the General Medical Council
* Should have membership of an approved Medical Defence Organisation
* Post Graduate Medical Qualification would be advantageous
* Typically two to three years’ post registration clinical experience