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Clinical Research Physician - Cambridge - Pharmaceutical Company

A new opportunity to work as a Clinical Research Physician for a small pharmaceutical company based near Cambridge.

Company:
A state of the art clinical research organisation focussed on early phase clinical development in a variety of therapeutic areas. Working extensively with many of the top 10 pharmaceutical companies.

Summary:
Reporting to the Medical Director, you will provide medical expertise and practical support to the Multidisciplinary study teams, in a manner consistent with ICH GCP. For the right candidate there is also the opportunity to be involved in activities outside the clinical environment.

Qualifications:
• Recognised medical degree.
• Full GMC registration.
• 2 Years post registration experience.
• Ideally a post graduate medical or pharmaceutical qualification.

Candidate requirements:
• Able to work within a structured business environment with strict regulatory control.
• Excellent team player with a flexible approach to work, an ability to work under pressure and to changing deadlines.
• Good interpersonal and communication skills to both internal/external customers.
• Understand clinical research business and associated processes and procedures.

Responsibilities:
• Act as Co-Investigator in studies, with specific responsibility for the safety and well-being of volunteers.
• Be fully conversant with the responsibilities of the Investigator, as defined in ICH GCP and the relevant UK legislation.
• Provide clinical input during the development of study protocols.
• Fully support the Study Management Function in interactions with Ethics Committees and Regulatory Authorities.
• Ensure that trial conduct is wholly compliant with International clinical and ethical standards, local ethical committee approvals and ICH-GCP.
• Plan and negotiate optimum medical support within the Medical Function, for performance of the clinical phase of research studies. Actively participate in the practical conduct of studies, with a ‘hands-on’ approach.
• Ensure clinical input to data analysis and interpretation for the clinical sections of final study reports for clinical studies, where applicable, including the drafting of agreed clinical sections of final study reports.
• Provide training and coaching to other members of the company in line with current or potential business interests.
• Support Business Development in their interactions with Sponsor organisations and outsource partners.
• Contribute to the development of new business directions by identifying potential areas of clinical research methodology, including the development and validation of new models applicable to research in healthy volunteers and patients.
• Maintain an awareness of new developments in clinical pharmacology, therapeutics, pre-clinical and laboratory testing, drug regulatory affairs and pharmaceutical medicine by attendance at appropriate meetings, seminars and workshops.
• Liaise with specialist consultants and academics where necessary or requested.
• Determining the suitability of subjects for inclusion in clinical studies in accordance with the study protocol.
• All medical decisions relating to the safety of subjects during the conduct of studies.
• Ensuring that considerations related to the well-being of the study subject take precedence over the interests of the trial, and those of the company.
• Working on a number of different trials at the same time, ensuring that all trials requirements are met on time and with absolute accuracy.