Vitaccess
Research Associate - RWE Site Monitor
United Kingdom
Posted 1 day ago
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Who you are…
With a scientific background working on clinical studies either in academia, a healthcare organisation, a CRO or other pharmaceutical consultancy setting, you’re looking for a role where you can use your skillset but want a new challenge.
- You’re experienced in working on clinical studies of various size and complexity across different geographies and disease areas and can apply your experience and knowledge to a range of projects.
- And you’ve got an excellent understanding of how studies are run at clinical sites in the US and UK in particular.
- You understand how site-based clinical studies are run - from identifying and setting up sites, managing sites through the data collection process and closing down a study (all of which you’ve done recently).
- You love turning your hand to a wide range of tasks and your consultancy toolbox is full: analytical mind, problem solver, evidence seeker, team player, customer focus, working to deadlines, rigorous, and attentive to detail.
- You’ve got experience and an interest in real world (observational) studies and can apply your experience in the clinical trial setting appropriately.
- You also have an interest in patient-focused research projects that involve collecting data from patients and carers as well as clinical data.
- You like working on exciting, diverse projects that involve cutting edge technology…and a lot of creative thinking as a result.
- You enjoy upskilling both study sites and your colleagues in new ways of thinking and working as part of a study.
- You’re comfortable working independently - this is especially important as we are a small team.
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What you’ll do…
- You’ll assist with all site set up activities from identifying sites, conducting feasibility assessments, selecting investigators, contracting with sites/local R&D departments, and providing sites with study materials and training.
- Along the way you’ll monitor the study, managing the site staff through the data collection process, conducting site visits, source data verification (SDV), and site payments.
- You will also help create and maintain the trial master file (TMF) and investigator site files (ISF).
- On completion of the study, you’ll close down the sites along with the completion of relevant documentation.
- You’ll contribute to the development of protocols and other study documents, like data collection forms and CRFs - you won’t be expected to write them but you will review them with the practical site-based aspects in mind.
- You’ll work with our consulting team to co-ordinate with ethics committees and assist with the writing and process of ethical applications.
- Most of your site-based work can be done remotely.
- A key part of your role will involve communication - not only with the sites but also with the rest of the Vitaccess study team and with our clients, attending project progress meetings and providing timely updates on study progress.
- We work collaboratively as a team and there will always be people to lend a hand or a friendly face to answer questions.
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Sorry, but it’s a no unless you have…
- Strong, recent experience in site-based healthcare studies is essential for this role.
- You’ll have a BA/BSc in science (all considered except sports and domestic), economics, mathematics, statistics, or a related discipline. And you’ll be fluent in English (spoken and written), with strong business/scientific written English.
- And, finally, we’re looking for fantastic time management and personal organisational skills, as well as mastery of the Microsoft Office suite and internet search tools.
Bonus points for…
- Strong experience working in the real-world setting, on patient/carer reported studies and using digital data capture platforms (beyond a traditional eCRF).
- If you have site management experience across different countries then we’d love to hear from you!
- We’re always happy to see candidates with languages other than English to a standard that is useful at work.
Team
Consulting
Locations
Remote (UK based)
Hours
80-100%; flexible hours
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Skills
Clinical Study Management
Site Monitoring
Real World Evidence
Source Data Verification
Site Feasibility Assessment
Protocol Development
Trial Master File Management
Investigator Site File Management
Data Collection
Clinical Trial Management
Microsoft Office
Analytical Thinking
Problem Solving
Time Management
English Fluency
Regulatory Compliance
Location