Clinical Research Associates(French or Spanish Speaking)
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Job Type | Temporary / Contract |
Location | City of London |
Area | Central London, UKFrance, Rest of World |
Sector | Clinical Research |
Salary | See Job Description |
Currency | GBP |
Start Date | ASAP |
Advertiser | remoteapi |
Job Ref | BBBH652_1518786085 |
Job Views | 302 |
- Description
We've got a great long term contract role for a native French or Spanish Speaking CRA's with excellent command of English to be based at our client's site in West London.
As a Clinical Research Associate (CRA) you will be responsible for performing and coordinating all aspects of clinical monitoring and site management, ensuring that country and site targets are achieved, in compliance with ICH/GCP, SOPs and all other applicable regulatory requirements.
Here is an Idea of what you wil be doing:
- Responsible for collation of trial related documentation (site contracts, consent documents, letters of agreement, confidentiality agreements), for Ethics committee submissions and renewals.
- Performs and coordinate all aspects of the clinical monitoring and site management.
- Conduct study site initiation meetings.
- Track patient recruitment and report on site issues/strategies to increase patient accrual into the trial (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
- First point of contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing studies.
- Oversee tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
- Ensure maintenance of project site files including:
- ethics committee approvals and reports,
- curricula vitae of investigators and study personnel,
- training/delegation log
- clinical documentation is current
- lab reference ranges are current
- investigator and site correspondence log
- schedules of payment.
- Conducts remote monitoring and site visits - assessing protocol and regulatory compliance, and reporting conduct using applicable documentation.
- Ensure site staff are trained in all protocol specific procedures and are ICH-GCP compliant.
- Comply with all applicable laws / regulations of each country in which we do business.
- Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians.
- Report legal, compliance and ethical violations in a timely manner.
The Must have Skills and Experience:- French or Spanish Speaking with excellent command of English
- Proven clinical trials experience
- Life science or other relevant degree
- Excellent organisational skills
- Proven ability to develop and update working practices
- Flexible and effective project management, communication and negotiation skills
- Ideally a strong understanding of cardio vascular disease and treatment
- Commutable to the Office which is based in West London
Candidates will need to have current and valid eligibility to work in the UK in order to be considered for this OFFICE BASED role.Pop Science are an innovative, personal and experienced recruitment and staffing consultancy. Our aim is to make science more popular by championing careers in clinical and scientific research, technology, engineering, maths and more. Whether you want a permanent job, a contract role or even a change in perspective with some volunteering, contact us and let us help you. We support working practises that promote happiness at work.
We're an experienced, skilled team with personality; we have a passion for science, and drive and enthusiasm to make a difference to you.
Find out more at Pop Science - Recruitment
- Experience
- French Speaking , Spanish Speaking Clinical Research Associate (CRA) will be responsible for performing and coordinating all aspects of clinical monitoring and site management, ensuring that country and site targets are achieved, in compliance with ICH/GCP, I SOPs and all other applicable regulatory requirements. Currently Recruiting, French and Spanish Speaking CRA’S Key Responsibilities: · Responsible for collation of trial related documentation (site contracts, consent documents, letters of agreement, confidentiality agreements), for Ethics committee submissions and renewals. · Performs and coordinate all aspects of the clinical monitoring and site management. · Conduct study site initiation meetings. · Track patient recruitment and report on site issues/strategies to increase patient accrual into the trial (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs). · First point of contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing studies. · Oversee tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion. · Ensure maintenance of project site files including: o ethics committee approvals and reports, o curricula vitae of investigators and study personnel, o training/delegation log o clinical documentation is current o lab reference ranges are current o investigator and site correspondence log o schedules of payment. Conducts remote monitoring and site visits - assessing protocol and regulatory compliance, and reporting conduct using applicable documentation. Ensure site staff are trained in TRI and protocol specific procedures and are ICH-GCP compliant. Comply with all applicable laws / regulations of each country in which we do business. Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians. Report legal, compliance and ethical violations in a timely manner. Desired Skills and Experience: Previous CRA experience in clinical trials Steady career history Life science or other relevant degree Excellent organisational skills Excellent interpersonal skills Ability to work to high standards Proven ability to contribute to the development of working practices Flexible and effective communication and negotiation skills Ideally a strong understanding of cardiovascular disease and treatment Experience of working in observational trials
- Qualifications
- Life Science Degree