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Associate Image Analyst (6-month FTC)

• London (Central), London (Greater) (GB)
• Competitive

mage analysis involves using different techniques to derive readings from brain scans.

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CRA II - North West

• Maidenhead, United Kingdom

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortre...

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• 10 days ago
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Senior Clinical Research Associate

• United Kingdom

Parexel are currently recruiting for an Senior Clinical Research Associate, to cover UK sites. In this role, the Senior Clinical Research Associate...

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• 19 days ago
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Senior Clinical Research Associate (CRA) - UK - Home-based

• Worldwide Clinical Trials

Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology

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Clinical Research Associate - Oncology

• United Kingdom, Homeworking
• ICON Strategic Solutions

Experienced, high-performing (Midlands/Northern England), UK-based CRA/clinical research associate required to augment existing Oncology CRA team, for

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CRA II / Senior CRA - 14 months FTC (PAYE) - Covering Sites in Glasgow and Edinburgh

• Syneos Health

Clinical Research Associate II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer s...

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• 13 days ago
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Senior CRA - FSP

• £45,000 - £60,000 (depending on experience)
• RBW Consulting

🔍 FSP CRA OPPORTUNITIES WITHIN PHARMACEUTICAL AND BIOTECH COMPANIES   Are you looking for a Clinical Research Associate role that can increase the...

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• 2 days left
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Senior CRA / CRA II

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research provid

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Senior CRA - Sponsor dedicated - Rare Disease - United Kingdom (homebased) - National travel across

• United Kingdom; Homeworking

CRA II / Sr. CRA Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We tra...

View details Senior CRA - Sponsor dedicated - Rare Disease - United Kingdom (homebased) - National travel across

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CRA - Sponsor Dedicated

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• 20 days ago
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Senior Clinical Research Associate

Job Details

Job description

The Kings Health Partners Clinical Trials Office (KHP-CTO) is a joint initiative between the member institutions of King’s Health Partners. It has been set up to provide a single interface for those wishing to conduct clinical trials within the partner institutions, and to ensure that there are common, efficient processes for the set up and administration of clinical trials. http://www.khpcto.co.uk .   

The KHP-CTO Quality Team was established in 2008 to manage the Sponsor responsibilities for Clinical Trials of Investigational Medicinal Products (CTIMPs), as defined in the Medicines for Human Use (Clinical Trials) Regulations, for trials sponsored or co-sponsored by King’s Health Partner Organisations. Also to assist Chief Investigators with the set up and initiation of their trials and to ensure that these trials are established and conducted according to Good Clinical Practice (GCP) and the Regulations 

The post holder will be required to:

• To lead a team of Clinical Research Associates/Administrators to ensure GCP compliance (through monitoring) and manage the sponsor responsibilities  of non-commercial trials on behalf of the Partner Organisations who are acting as sponsor or co-sponsor to ensure regulatory compliance. 
• To set up and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor, to ensure regulatory compliance. 
• To provide support to investigators to ensure they are working to the highest quality standards and to monitor and report on the progress of trials across the partner institutions where one or more of the partners is acting as sponsor or co-sponsor. 

The post holder will ensure that investigators and their teams run trials according to sponsor’s SOPs, prevailing regulations and best research practice by providing advice, practical assistance and carrying out monitoring functions as appropriate. 

This post will be offered on an indefinite contract contract.

This is a full-time post - 100% full time equivalent. Part time applications will be considered.

Key responsibilities

• To assist the Quality Manager (QM) and R&D staff in the partner institutions to ensure that all trials sponsored or co-sponsored by the partner organisations are conducted in accordance with the current UK and EU Clinical Trial legislations and the KHP-CTO SOPs.  
• To provide day to day line management of a team of Clinical Research Associates (CRAs) and Clinical Trial Administrators (CTAs). Activities to include: - 
• Reviewing and approving Monitoring Visit Reports 
• Advise and assist CRAs, conducting co-monitoring visits as required. 
• In discussion with the QM, allocating trials to team members and assessing workload of individuals within the team. 
• Assisting KHP-CTO Director and QM with staff recruitment as necessary.  
• Set and monitor objectives and foster junior staff development. 
• Conduct staff appraisals in line with KCL Policy. 
• To ensure that development safety update reports, pharmacovigilance reports and protocol amendments are submitted to the MHRA thereby maintaining Clinical Trials Authorisations. 
• To set up, initiate and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor. Monitoring to be conducted according to Monitoring Plans agreed by the Sponsor institution and the Quality Manager. 
• To assist the Quality Manager in the conduct of Regulatory Inspections and sponsor audits for both commercially sponsored and non-commercially sponsored trials on behalf of the partner institutions. 
• To maintain a working knowledge of prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials. 
• To ensure confidentiality of commercially sensitive information and to ensure data protection imperatives are respected. 
• To act as an ambassador for the KHP-CTO. 
• To work with other Senior CRAs, CRAs and other staff within KHP-CTO to promote a quality environment and ensure that all trials are conducted in compliance with the regulations and GCP. 
• To contribute to the day to day management of the KHP-CTO. 
• To liaise closely with the Partner Trusts’ R&D Departments and Research Management & Innovation Directorate staff within KCL, to ensure compliance with the NHS Research Governance Framework, College policies and contractual obligations for clinical trials are met. 
• To assist in the prevention, detection and management of clinical research fraud, malpractice and misconduct. 
• To provide advice on GCP and related matters to those wishing to conduct clinical trials across the partner institutions. 
• Using a problem solving approach whenever possible. 
• Assisting the QM in development and implementation of SOPs as required. 
• Development of trial risk assessments and trial monitoring plans. 
• Assist trial Investigators with the development and review of clinical trial protocols to ensure quality regulatory compliance. 
• To prepare and submit Clinical Trials Authorisation Applications to the MHRA. 
• Assisting the Director and QM in collation of metrics and trial data. 
• To lead and work flexibly as a member of a team. 
• To assist the Clinical Trials Training Executive(s) in the education and training of trials active staff.  This training to include GCP guidelines, relevant legislation and the research governance framework and to be delivered to staff conducting commercial and non-commercial trials. 
• To support Investigators and their teams to conduct clinical trials in line with UK   Regulations. 

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

Skills, knowledge, and experience

Essential criteria  

• Educated to degree level preferably in a related subject area, e.g. a life science or clinical subject. 
• In depth knowledge of the regulatory requirements for clinical trials and GCP 
• Strong interpersonal, communication, influential and problem solving skills including the ability to build successful relationships and collaborate in a cross-functional team and maintain a positive work environment 
• Ability to develop, implement and work to SOPs 
• Excellent written and verbal communications skills 
• Proven leadership skills and Experience of mentoring or facilitating others  
• Excellent organisational and time management skills 
• Suitable experience as a Clinical Research Associate gained in the pharmaceutical industry and/or NHS/Academic environments  
• Willingness to travel on occasion including overnight stays 
• Excellent interpersonal skills – tactful and being able to deal with a wide range of people in an enthusiastic and helpful manner whilst being capable of firmly maintaining policies and regulations

Desirable criteria

• Good presentational, organisational, and administrative skills 
• Experience of a Regulatory Inspection   
• Line management experience 
• Experience and knowledge of working within the NHS Research Governance Framework 
• Experience of setting up and monitoring clinical trials within the NHS/Academic Sector

Further information

The post will be based in the Research Management Hub within the R&D Department at Guy’s Hospital, Tower Wing. However, it is a requirement of employment that the post holder works at any of the KHP Partner NHS Trusts hospital sites or King’s College London campuses as required to effectively deliver the role and responsibilities.   

As part of our commitment to a progressive working culture, King’s provides opportunities for hybrid working – a mix of on campus and home working: the amount of time that staff are required on site is determined by the needs of their role. 

Appointment within discretionary spine points will be considered based upon experience. 

King's College London is one of the top 20 universities in the world and among the oldest in England. King's has more than 27,600 students (of whom nearly 10,500 are graduate students) from some 150 countries worldwide, and some 6,800 staff.

King's has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF) King’s was ranked 6th nationally in the ‘power’ ranking, which takes into account both the quality and quantity of research activity, and 7th for quality according to Times Higher Education rankings. Eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*). The university is in the top seven UK universities for research earnings and has an overall annual income of more than £684 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org .

King’s £600 million campaign, World questions|KING’s answers, has delivered huge global impact in areas where King’s has particular expertise. Philanthropic support has funded new research to save young lives at Evelina London Children’s Hospital; established the King’s Dickson Poon School of Law as a worldwide leader in transnational law; built a new Cancer Centre at Guy’s Hospital; allowed unique collaboration between leading neuroscientists to fast-track new treatments for Alzheimer’s, Parkinson’s, motor neurone disease, depression and schizophrenia at the new Maurice Wohl Clinical Neuroscience Institute; created the Cicely Saunders Institute: the first academic institution in the world dedicated to palliative care, and supported the King’s Sierra Leone Partnership in the Ebola crisis. Donations provide over 300 of the most promising students with scholarships and bursaries each year. More information about the campaign is available at www.kcl.ac.uk/kingsanswers .

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Clinical research associate

Clinical drug research is a competitive but growing field and work experience in a scientific or healthcare environment is crucial for a job as a clinical research associate

As a clinical research associate (CRA), you'll run clinical trials to test drugs for their effectiveness, risks and benefits to ensure that they are safe for the intended use.

You'll work on new and existing drugs and will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.

Clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects.

Responsibilities

Tasks vary depending on your employer and level of experience. However, you'll typically need to:

• develop and write trial protocols (outlining purpose and methodology)
• present trial protocols to a steering committee
• design data collection forms, known as case report forms (CRFs)
• coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
• manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
• identify and assess the suitability of facilities to use as the clinical trial site
• identify/select an investigator who will be responsible for conducting the trial at the trial site
• liaise with doctors, consultants or investigators on conducting the trial
• set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
• train the site staff to trial-specific industry standards
• monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
• verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• collect completed CRFs from hospitals and general practices
• write visit reports and file and collate trial documentation and reports
• meet with team members to discuss on-going trials, results and any trends or adverse events
• ensure all unused trial supplies are accounted for
• close down trial sites on completion of the trial
• discuss results with a medical statistician, who writes technical trial reports
• archive study documentation and correspondence
• prepare final reports and occasionally manuscripts for publication.
• Starting salaries for CRAs are in the region of £26,000 to £34,000. It's likely these posts will require some experience in a related area.
• As a senior CRA (SCRA), also known as a CRA II, you can earn a salary of around £35,000 to £50,000.
• In some senior roles, as a manager or director, salaries of in excess of £55,000 can be achieved.

Salaries vary from company to company. Additional benefits, such as a car allowance and bonus and pension, are typically offered.

Income figures are intended as a guide only.

Working hours

Working conditions vary between companies, although the hours are usually full time, Monday to Friday. You should expect to work some evenings, although weekend or shift work is uncommon.

Part-time work is possible, as are career breaks. Short term contracts of six to 12 months with a company are common, meaning you may work more like a contractor than a permanent employee.

What to expect

• It's likely your role will be a mixture of desk-based work and site visits. You'll visit trial sites to set up and close down a trial as well as to monitor the trial while it is running which could involve visits every four to six weeks. Some trials may be running abroad which will involve international travel. There may be opportunities for home-working the remainder of the time. In some instances you may find a role that is almost exclusively office-based with the focus being on document review.
• Most UK pharmaceutical companies are located in the south of England. Field-based positions are generally found in key locations throughout the UK. Some jobs, for example in a company laboratory, can be found locally, while others are regionally based.
• Self-employment or freelance work is possible once you've gained significant experience.
• The job can involve a lot of travelling and you may be out of the office three or four days a week, possibly including overnight stays. Some companies operate a system whereby the CRA specialises in a specific disease area and covers the whole of the UK. Others operate their CRAs on a regional basis.
• Initiatives are in place to encourage more women into science-based careers, such as Women in STEM .

Qualifications

To become a clinical research associate (CRA) you need to have a degree in life sciences, medical sciences or nursing.

This could include subjects such as:

• biochemistry
• biomedical science
• microbiology
• molecular biology
• pharmacology or pharmacy
• toxicology.

Entry without a degree or with a HND only is unlikely. You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator/assistant. However, you would need substantial experience and further qualifications to progress to the role of CRA.

A postgraduate qualification is not essential, with many employers only looking for a related undergraduate degree. However, it could give you valuable experience in clinical trials and may be an advantage against competition when applying for jobs. A relevant PhD can also be advantageous in some companies, who may consider it as highly-relevant work experience counting towards gaining promotion to senior positions or moving into protocol development. Check with desired employers to find out what they're looking for.

Search for postgraduate courses in clinical research or clinical trials .

You'll need to have:

• excellent communication, both written and verbal, and interpersonal skills
• the ability to build effective relationships with trial centre staff and colleagues
• the ability to motivate others
• strong customer focus
• an excellent grasp of numeracy and a keen eye for detail
• presentation skills
• the ability to multitask and think on your feet
• project management skills
• a flexible and adaptable approach to work
• organisational, IT and administrative skills - the job involves a lot of documenting and recording information through computerised processes, such as clinical trial management systems and electronic data capture
• an understanding of the importance of good clinical practice (GCP) , which is a legal requirement for all CRAs.

You'll usually need a clean driving licence for travel between trial sites and your office.

Skills in an additional language, particularly any European ones, may also be useful for roles abroad.

Work experience

Relevant experience is crucial for securing a job as a CRA. Without it, you're likely to start work at a lower level, as a clinical data coordinator or clinical trials administrator/assistant, where you won't be involved in initiating or designing the trials. Once you've gained experience, you will then move on to a full CRA position.

A small number of companies may recruit graduates without experience if they have the necessary personal skills, but it's more likely that employers will look for someone who has some actual experience in a related workplace. This can include any work that uses scientific and analytical skills, for example:

• academic or pharmaceutical research
• clinical data work
• clinical laboratory work
• medical sales
• nursing or care work

Another useful way of gaining experience is to complete an industrial placement as part of your undergraduate degree. This can give you the real-world experience in a related area as well as helping you to make contacts that could lead to potential job offers in the future.

Competition for jobs is strong and work experience in a clinically-relevant field will considerably improve your chances.

Find out more about the different kinds of  work experience and internships  that are available.

Typical employers include pharmaceutical companies, medical device manufacturers, biotech companies and contract research organisations (CROs), which conduct research on behalf of pharmaceutical companies.

A CRO will organise the placement of a CRA on behalf of the sponsor (the pharmaceutical company) and may be involved in planning, organising and conducting the whole study or just part of it. The CRA will report back to the organisation and will feed back to the sponsor.

Large contract organisations are more likely to recruit an inexperienced graduate into a monitoring role and provide the training to progress to the level of a CRA.

Hospital academic departments occasionally employ CRAs in clinical trials units.

Look for job vacancies at:

• BMJ Careers
• emedcareers
• New Scientist Jobs
• Pharmiweb Jobs

Contract research organisations and pharmaceutical companies may advertise vacancies on their own websites.

Specialist recruitment agencies also handle vacancies. These include AL Solutions and RBW Consulting .

Professional development

Training takes place mainly in-house and on the job. The nature of the training can vary from company to company, with some employers providing a structured system.

Some companies will pay for relevant external training courses through organisations such as the Institute of Clinical Research (ICR) . They provide training in areas such as:

• advanced monitoring
• effective project management for clinical trials
• essentials of clinical trial monitoring
• process thinking in clinical trials.

You can also complete the ICR Certificate and Diploma to provide evidence of your clinical research knowledge and skills.

Becoming a member of the ICR can aid career development as it provides networking opportunities, discounted training, specialist interest groups and access to industry news. You can progress through the ICR membership levels but to do so you'll need to undertake a certain amount of continuing professional development (CPD) each year.

If you don't already have a postgraduate qualification, you can take a postgraduate certificate, diploma or Masters in areas such as:

• clinical pharmacology
• clinical pharmacy
• clinical research
• pharmaceutical medicine.

It's also possible to do a PhD. These courses can facilitate professional development and career advancement but you should check this against the career route you want to follow and employers of interest.

Career prospects

Career structures vary from company to company. How quickly you move up the grades depends on a range of factors including motivation, the opportunities available for training and development, ability and previous experience.

Before becoming a CRA, you may begin at a lower level such as a clinical trial administrator or junior CRA. As a CRA (also known as a CRA I), you'll work on pre-trial procedures, setting up and organising clinical trial sites (with some supervision), archiving documents and correspondence.

With the right combination of skills and experience you can move into the role of senior CRA (SCRA), also known as a CRA II. Work will include selecting investigators, coordinating ethics committee and regulatory authority applications, supervising trial supplies and attending investigator meetings.

As you progress further you'll also be responsible for supervising, training and mentoring junior staff, project management of whole trials (possibly on an international scale), protocol development and design of case report forms (CRFs). You could become a clinical team manager, clinical trial manager or clinical project manager depending on where your interests and skills lie. Beyond this are director roles within the same areas.

If you work within a contract research organisation you can build up and widen your experience with a variety of sponsor pharmaceutical companies in different therapeutic areas and in different phases of clinical research. This could allow you to move to a pharmaceutical company.

Self-employment may be possible as CRAs are employed on a freelance basis by certain companies. This should usually only be considered when you have developed experience, contacts and clients.

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You are now leaving this website. By continuing, you will be directed to a site intended only for residents of the United States and Canada. We are called MSD everywhere, except in the United States and Canada where we are known as Merck & Co Inc, Rahway, NJ USA.

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Clinical Research

A patient-first focus and the freedom to chase something big,   let us tell you about the important work we're doing ​​​​​​​ in clinical research​​​​​​​, meet the talent, we asked, and here are the standout reasons people are joining and staying with our clinical research teams.

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• A wide, robust pipeline of game-changing products
• State-of-the-art labs
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Senior Research Associate in Mathematical Modelling of Infectious Diseases

University of bristol - clinical epidemiology and public health.

This post offers an excellent opportunity for a Senior Research Associate to join a multi-disciplinary research team of mathematical modelers, epidemiologists and health economists based in Population Health Sciences at Bristol Medical School. The post-holder will contribute expertise in mathematical modelling on the transmission dynamics and impact of interventions on HIV, HCV and other infections. The post is funded until 31/03/2025 in the first instance and will provide a valuable opportunity for obtaining research training and experience.

What will you be doing?

The post will involve undertaking mathematical modelling, epidemiological analyses and economic evaluations focussed on evaluating the impact of different interventions addressing the epidemics of HIV and HCV among PWID in different countries. You will be involved in the technical aspect of modelling, developing models of HIV and HCV among people who use drugs, undertaking data analyses to parameterise the model, and using the models to undertake economic evaluations. You will collaborate with other members of the team involved in these projects. There may also be the opportunity to collaborate on projects which focus on other infections and population groups.

You should apply if

Additional information

Contract type: Open-ended with funding until 31/03/2025

Work pattern: Full time/ 1 FTE

Shift pattern: 35 hours per week

This advert will close at 23:59 GMT on 03/04/2024

For informal queries please contact: Peter Vickerman ( [email protected] )  and Jack Stone ( [email protected] ) Zoe Ward ( [email protected] )

Our strategy and mission

We recently launched our  strategy  to 2030 tying together our mission, vision and values.

The University of Bristol aims to be a place where everyone feels able to be themselves and do their best in an  inclusive working environment where all colleagues can thrive and reach their full potential.  We want  to attract, develop, and retain individuals  with different experiences, backgrounds and perspectives – particularly people of colour, LGBT+ and disabled people - because diversity of people and ideas remains integral to our excellence as a global civic institution.

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