Clinical Research Associate - London

I am currently recruiting for a CRA on a 6 month contract - 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.

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:
  • 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 client 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:

• 3 + years CRA experience in clinical trials
• Life science or other relevant degree
• Excellent organizational skills
• Excellent interpersonal skills
• Fluent in French and/or Spanish
• 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
• Ideally have experience of working in observational trials

Candidates will need to have current and valid eligibility to work in the UK in order to be considered for this role.