Clinical Research Facility Research Physician

Job description

Job responsibilities

As the CRF Research Physician, the post holder will:

Support the timely delivery of clinical studies to acceptable medical standards, in-line with the requirements of sponsors, ICH GCP, and other appropriate guidelines and regulations.

Provide medical assessment and cover for selected studies in the CRF working alongside the

CRFs senior clinical team and nurse in charge for the day;

In partnership with the CRF Directors and staff, initiate definitive strategies to anticipate and expertly manage medical safety issues, including emergencies;

Support aspects of subject recruitment, including pre-study medical histories, informed consent, medical examinations for ongoing studies, dosing of study medication;

Where required, provide medical cover outside of normal working hours, as determined by the nature of the studies being undertaken in the CRF at the time;

Accept delegated responsibility to ensure that assigned studies in the CRF are carried out safely and in compliance with the protocol;

Be responsible for specific study-related medical decisions as agreed with the Study Principal Investigator;

Perform clinical procedures as appropriate to the assigned study (including, but not limited to, clinical examinations or testing, insertion of intravenous lines, assessment of adverse events and management of medical emergencies);

Ensure that patients/volunteers in assigned studies give fully informed consent in writing before commencing a study;

Assess the eligibility status of referrals for experimental treatments, maintain and update a screening list.

Evaluate and manage acute, sub-acute and chronic adverse drug reactions and manage acute toxicological emergencies under the supervision of the consultants in charge.

Assess and interpret safety and clinical data from assigned studies, e.g. Vital signs, ECG's, laboratory tests, adverse events etc;

Follow up and report adverse events as necessary. Communicate safety issues to the Principal Investigator for a study, the Head of Department or Designee, report Serious Adverse Events to the study sponsor in accordance with Good Clinical Practice;

Review study documentation and complete appropriate sections of Case Report Forms;

Ensure that all clinical activities within the CRF are conducted in accordance with approved Standard Operating Procedures (SOPs)

Participate in the writing, and review, of appropriate CRF SOPs in association with senior medical colleagues and CRF Quality Team;

Maintain accurate and accessible research records and medical notes;

Provide medical input into integrated clinical, safety and statistical reports as requested;

Contribute to the risk assessment and planning of risk mitigation strategies for early phase trials;

Provide medical input and review of study protocols and other related study documentation and participate in research meetings, study review meetings, and meetings with principal investigators and study sponsors;

Maintain awareness and keep abreast of latest technologies in the medical field and share that knowledge with the Quintiles Drug Research Unit clinical team and CRF team;

Prepare reports for submission to pharmaceutical companies, regulatory bodies, and medical and scientific journals as appropriate;

Ensure personal Trust mandatory training is up to date and support the training of medical, nursing and ancillary staff as required;

Assist with business development activities as appropriate including the development and maintenance of professional relationships with local opinion leaders and other GSTT/KCL departments;

Develop and maintain computer skills to utilise available systems for the efficient management and administration of the day to day activities of the CRF;

Any other duties as may be deemed reasonable by the CRF Directors.

To participate in clinical and other service activities with the object of ensuring a high standard of patient care

To participate in undergraduate and postgraduate teaching and training

Person Specification

qualifications/training

Essential

• MBBS or equivalent medical qualification

Desirable

• MRCP or equivalent
• Good Clinical Practice (GCP)
• Advanced Life Support ALS

Experience

Essential

• evidence of achievement of foundation and IMT competencies or equivalent
• good clinical care and maintenance of good medical practice
• good relationships with colleagues and patients
• professional behaviour and probity

Desirable

• previous experience within respiratory medicine

Skills

Essential

• audit

Desirable

• teaching and research ability

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Royal Brompton Hospital

Sydney Street

London

SW3 6NP

Employer's website

https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)