Description:
Location: United Kingdom - Home-based

Schedule: Part Time, Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Freelance Clinical Research Associate (CRA) to join our client-based team at one of the leading global biopharmaceutical companies.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Main Job Tasks and Responsibilities:

• Conduct pre-study site assessments and identify sites and PIs suitable to conduct the study
• Prepare and review site study documentation
• Support and facilitate institutional, ethics and regulatory approval where required
• Conduct and support site training and site initiation visits
• Conduct monitoring at study sites and remotely, including SDV to ensure the study meets procedural and GCP requirements
• Conduct study site close-out activities
• Write-up study site visit reports
• Manage site level Trial Master File (TMF)
• Review site level recruitment with site study teams
• Track site level expenditure against contract and ensure appropriate invoices are raised
• Attend regular CRA and cross-functional meetings as required

Education and Experience:

• At minimum, educated to degree level or equivalent in life sciences
• Relevant clinical research experience
• Experience of working with medical devices and European regulations/standards affecting clinical investigations (e.g. ISO14155)
• Experience of using an electronic TMF
• Knowledge and experience of diabetes and/diabetes related trials

Specific Role Requirements and Skills:

• Work within a study team
• Communicate well both verbally and in writingInteract confidently with study stakeholders
• Communicate in English language
• Complete submissions to Ethics Committees in Germany to obtain study approval
• Independently raise and discuss difficult issues
• Deliver studies according to Good Clinical Practice (GCP) and Sponsors SOPs
• Analyse and digest product and clinical information
• Use Electronic Data Capture systems to review data collected
• Communicate well both verbally and in writing
• Willingness to travel to UK regularly and throughout Germany

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @

https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Research Associate, CRA, Freelance, Contract, Clinical Trials, Clinical Research, Diabetes, Medical Devices, Pharma, Pharmaceutical, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated
Skills: Clinical Research Associate Location: United Kingdom Share:

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