Clinical Research Physician London - Pharma

Clinical Research Physician

The job specification below shows the breadth of work covered by the Research Physicians and Senior Research Physicians within. The focus of a Research Physician work is expected change with seniority. In general, the specification shown below is presented in a probable chronological order i.e. the focus of work progresses down the specification with seniority.

 Requirements:

• Medical Doctor UK Trained
• FY1 & 2 completed
• 2 years post foundation experience
• Motivated to get into industry

Volunteer screening in preparation for clinical trials

• To obtain informed consent from subjects prior to inclusion into a study.
• To perform medical screening on healthy volunteers and patients including medical history taking, physical examination and review of laboratory reports according to the study protocols.
• To collate necessary medical documents and information to make informed decisions about inclusion onto a clinical trial.
• To review all Case Report Forms with regard to inclusion/exclusion of subjects prior to commencement of the study.

Clinical trials procedures

• To be familiar with all current study protocols.
• To discuss protocols in-house and with sponsors and experts.
• To supervise all safety aspects during the studies.
• To maintain knowledge, understanding and practice of general medical practice and to maintain Advanced Life Support skills.
• Evaluate and treat all Adverse Events that arise during studies and prepare safety reports.

 Reporting

• To produce and update case reports for volunteers who experience Serious Adverse Events or other notable Adverse Events.
• To review and analyse safety, pharmacokinetic and pharmacodynamic data and present the findings in interim reports.
• To participate in the discussions regarding the impact data in interim/safety reports has on clinical trial progression.

Medical writing

• To contribute to the writing of Study Operations Manuals for upcoming studies and update as appropriate during the conduct of ongoing studies.
• To write Patient Information Leaflets/Informed Consent Forms for planned clinical studies.
• To review study protocols and to participate in the generation of study protocols as required.

Regulatory work

• To write relevant sections of Patient Information Leaflets/Informed Consent Forms. 
• To review and contribute to the development of Investigator’s Brochures when required.
• To review and implement recommendation from scientific advisory meetings into relevant study documents in preparation for submission.
• To participate in discussions with scientific and other experts in preparation for regulatory submissions.