Senior Clinical Research Associate (CRA III) required for a one year 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 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:

• 5 + years CRA experience in clinical trials
• Life science or other relevant degree
• Excellent organizational 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

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

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