clinical research associate

clinical research associate Cambridge, East of England, England

GSK
Full Time Cambridge, East of England, England 63000 - 37533 GBP ANNUAL Today
Job description

clinical

Site Name: UK - Cambridgeshire - Addenbrookes
Posted Date: Jul 25 2023


Are you looking for a role where you can provide high quality clinical care during the conduct of clinical trials of investigational medicinal product/s and experimental medicine studies? If so, this is the role for you.

The CUC is a 24 bed MHRA accredited Phase 1 Unit, conducting early phase work for GSK, including FTIH and experimental medicine studies. We support Discovery Medicine (DM), Vaccines, Global Health and Clinical Sciences (late-stage development). The unit has the ability to recall participants by genotype and phenotype for ex-vivo pharmacology experiments and assay development, and interacts with DM, multiple other groups within the wider GSK, as well as collaborations with Addenbrooke’s Hospital.

As Clinical Research Physician you will work alongside GSK wider functions and the multidisciplinary research team at the GSK CUC holding specific responsibilities for the management and coordination of clinical studies and safety governance for GSK clinical research.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Effectively manage study teams focusing on quality, on-time and on-budget delivery of clinical trials.
  • Builds effective networks, within and outside GSK whilst promoting a professional and positive image of the CUC both internally and externally. Working closely with members of the central GSK teams, to provide CUC expertise into the medical and scientific aspects of study plans and protocol, FTIH and early clinical development/translational medicine.
  • Acts as co-Investigator or Principal Investigator (PI) on clinical studies, including clinical pharmacology studies, experimental medicine studies and First-Time-In-Human (FTIH) studies.
  • Responsible for protocol-related activities, including supporting participant recruitment, obtaining informed consent, medical screening, performing ongoing monitoring and post-study clinical examinations, review and interpretation of vital sign, ECG, spirometry, Holter and laboratory test results.
  • Responsible for safe dosing of study medication including investigational medicinal products (IMPs) and non-IMPs, through all routes of administration, e.g. oral, intravenous, subcutaneous.
  • Provides complete medical cover for recruitment of volunteers and patients, during study conduct, and study follow-up. Provision for the on-call out of hours cover, and provides cover on a rota basis, in conjunction with the other physicians.
  • Responsible for medical safety and governance decisions.
  • Develops strategies to anticipate and expertly manage medical safety issues, including emergencies; Management of adverse events and medical emergencies.
  • Ensures compliance with acceptable medical standards and the requirements of the protocol, standard operating procedures, ICH GCP, Research Ethics Committees (RECs), regulatory authorities and other applicable guidelines and regulations.
  • Opportunity to lead projects outside of classic study work and liaise with wider GSK teams.
  • Ensure standards are maintained to enable the delivery of consistent high quality and safe clinical trial conduct, at the CUC, through relevant audit and quality improvement and governance activities.
  • Accountable for authoring (where required) and reviewing and approving the Informed Consent Form (ICF) and relevant Research Ethics Committee (REC) submission documentation.
  • Accountable for responding to questions from RECs, and regulatory authorities as required.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • MBBS or equivalent with Full registration with UK General Medical Council with a license to practice.
  • UK trained doctors: at a minimum, will have completed their early Specialty or General Practice training (Postgraduate Membership of a Royal College is desirable) and have relevant acute medicine experience.
  • Doctors who have trained outside of the UK, will be able to demonstrate equivalent qualifications and experience of clinical practice in acute care of patients and obtain GMC registration.
  • Leadership skills to effectively manage study teams focussing on quality, on-time and on-budget delivery of clinical trials. Working with central GSK teams (discovery medicine etc) on FTIH and early clinical development/translational medicine.
  • Experience in clinical pharmacology in early phase I/II studies in a clinical or academic setting.
  • Commitment to train toward and/or the Advanced Life Support Provider (as a minimum) qualification of the UK Resuscitation Council (UK).
  • Strong verbal and written communication skills, ability to present and think critically along with a strong academic background.
  • Excellent interpersonal skills and energy to operate in a complex organisation environment, positive mindset and willingness to learn and develop in the role.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Depending on experience/ accreditation may act as Principal Investigator on FTIH studies but not a requirement.
  • A relevant post-graduate qualification in clinical pharmacology is desirable. It is expected that work will be undertaken in this role, towards qualification for becoming a first time in human principal investigator.

Why GSK?

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using the science of the immune system, human genetics and advanced technologies to get ahead of infectious diseases, HIV, cancer and immune-mediated and respiratory diseases. We do all this with a commitment to operate responsibly for all our stakeholders by prioritising Innovation, Performance and Trust.

Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and treatments, including innovative new products, will reach more people who need them more than ever before.

We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That’s why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about our ambition for GSK to be a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where people can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

We’re also working hard to become more inclusive in the way we do business. We’re building demographic planning into our clinical trials, so they reflect the real-world population that’s affected by the disease we’re studying. We’re engaging with diverse-owned suppliers that meet our standards and share our values. We’re also inspiring the next generation of diverse scientists by investing in STEM education programmes to improve career opportunities for people in under-represented communities.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

clinical research associate
GSK

www.gsk.com
Brentford, United Kingdom
Emma Walmsley
$10+ billion (USD)
10000+ Employees
Company - Public
Biotech & Pharmaceuticals
1830
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