Clinical Research Physician

• *Recognise, exemplify and adhere to ICON's values which centres around our commitment to People, Clients and Performance.
• *As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (up to 10%) domestic and/or international.
• *Work within the context of the Unit’s Standard Operating Procedures.
1. *Recruitment and screening of volunteers and patients
• To inform volunteers and patients of all aspects of a study, prior to participation, and obtain written and fully informed consent.
• To be responsible for conducting the clinical evaluation of healthy volunteers and patients for specific studies through thorough medical history and physical examination.
• To inspect laboratory biochemistry, haematology, microbiology and ECG results and assess their significance in relation to volunteer and patient participation in studies.
• To assess eligibility of subjects for clinical trials against the inclusion and exclusion criteria in the context of sound clinical judgement.
• To assist in maintaining and updating the volunteer database, ensuring a good level of communication with Volunteer Recruitment and Screening Services.
2. *Conduct of studies
• To act as Co-Investigator for studies, actively supporting the Principal Investigator in the supervision of the conduct of studies and ensure that the protocol is strictly adhered to, in accordance with ICH-GCP.
• To prescribe study drug in accordance with the protocol.
• To assist in the correct drug dosage and administration procedures as necessary.
• To assist nursing staff in the insertion of intravenous cannulae for venous access utilising current best practice.
• To assist with collection of blood and other samples as determined by the protocol and Clinical Unit requirements.
• To conduct physician-specific safety and pharmacodynamic assessments as determined by the protocol.
3. *Supervision of the safety of volunteers/patients during studies
• To maintain a high standard of subject welfare and safety alongside exemplary data integrity.
• Monitor study subjects at least once daily whilst resident in the Clinical Unit through clinical evaluation, safety laboratory tests, ECG recordings and other pharmacodynamic assessments as determined by the study protocol, initiating additional procedures where appropriate to enhance subject safety.
• Monitor any adverse reactions should they occur and conduct further examination and investigations based on clinical judgement.
• Complete the Case Report Form with specific reference to the Adverse Event recording, reviewing these frequently and ensuring follow up to resolution.
• To present study-specific safety issues at the weekly Clinical Safety Meetings, ensuring the rest of the physician team are adequately briefed regarding studies for which they have responsibility.
• Ensure good communication with nursing staff with regards to subject welfare and safety.
• Be available on a rostered 24-hour on-call basis for volunteer/patients on a rotational basis.
4. *Study protocols/reports
• Assist project management in the leadership of studies.
• To meet and discuss details of studies with representatives of Sponsor companies, helping to develop the protocol, advising on medical and safety issues and providing regular updates to Sponsors as necessary. This will be done with the knowledge and support of the Principal Investigator.
• To attend Research Ethics Committee meetings when invited and to present proposed study protocols to the Ethics Committee, highlighting specific safety and ethical issues for consideration.
• To take a leading role in the review and development of clinical protocols, summaries, safety and final study reports.
5. *Development and maintenance of expertise
• To develop and maintain a high level of skills in designing, conducting and interpreting clinical pharmacology studies by reading relevant scientific literature and through attending courses/conferences/symposia.
• To participate in continued professional development (including Higher Medical Training/Specialist Training) through enrolment of courses leading to additional qualifications such as the Diploma in Pharmaceutical Medicine or Diploma in Human Pharmacology.
• To maintain a high level of awareness of major issues in general medicine and the pharmaceutical industry.
• To maintain a high level of clinical skills in the management of medical emergencies, including the management of the cardio-respiratory arrest/peri-arrest scenario in accordance with best medical practice and nationally recognised guidelines, including those published by the Resuscitation Council (UK).
• Maintain acute care skills.
• Take part in regular and systematic audits, responding to the audit results by improving practice, for example by undertaking further training.
• To maintain a training record and portfolio of activity.
• Any other duties as assigned commensurate with skills and qualifications and appropriate to the role.