Clinical Research Associate II (CRA) - US & Canada

Role overview

CYTE Global is seeking a careful, proactive Clinical Research Associate to help deliver global observational clinical studies successfully. This position is centered on managing assigned study sites from start to finish, with a strong focus on protocol adherence, ICH-GCP compliance, regulatory standards, and internal SOPs. The role also involves developing productive working relationships with investigators, sponsors, and internal stakeholders.

The position is based in London and is largely office-based, while also requiring remote monitoring of international sites. Prior independent monitoring experience in the United States and Canada is mandatory.

About the company

CYTE Limited is a cardiovascular contract research organisation delivering end-to-end research and development support to biotech and pharmaceutical clients. Its global offering includes a site network of nearly 3,000 sites across 40 countries, an integrated clinical platform for users, and specialist CRO services.

Clinical monitoring and site management

You will oversee site qualification, initiation, routine oversight, and close-out activities through remote and on-site visits. The role requires ensuring participant safety, strong data quality, and adherence to protocols and regulatory expectations.

You will also track site performance, enrollment progress, and study milestones; produce monitoring reports; handle site questions; carry out corrective actions; and act as the main point of contact for assigned sites.

Study start-up and regulatory support

The role includes contributing to feasibility assessments, site selection, ethics and regulatory submissions, site activation, and the preparation of essential study documents.

You will help coordinate agreements, budgets, informed consent materials, and communication with sponsors, investigators, ethics committees, regulators, and vendors.

Documentation and data quality

You will keep Trial Master Files and Investigator Site Files complete, current, and inspection-ready, with documentation maintained to a high standard of accuracy and compliance.

Additional responsibilities include reviewing case report forms and study data, resolving data queries, supporting participant recruitment, and guiding site staff on protocol requirements.

Training, compliance, and collaboration

In this role, you will provide protocol and ICH-GCP training to site teams, maintain strong working relationships across internal and external stakeholders, and support collaborative delivery of study objectives.

You will be expected to identify and escalate quality or compliance concerns and contribute to ongoing process improvement while upholding the highest ethical and regulatory standards.

Requirements

Applicants should hold a bachelor’s degree in Life Sciences or another related scientific field. The role calls for 1 to 2 years of experience working as a Clinical Research Associate in clinical trials, including at least 12 months of independent site monitoring.

Experience with both remote and on-site monitoring visits is required, and prior monitoring of clinical trial sites in the United States and Canada is essential. Candidates must also demonstrate solid knowledge of ICH-GCP, clinical trial regulations, and clinical research processes, along with strong organisation, communication, attention to detail, problem-solving ability, and the confidence to work independently as part of a wider team.

Work location

This is an office-based role in London, UK, with remote monitoring responsibilities for international study sites.

Additional information

The title for this position is Clinical Research Associate II (CRA). The role supports global observational clinical studies and requires a hands-on approach to site management and study execution.