Performs and coordinates all aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting source data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and close out visits at investigational sites.
In this role, you will build and manage a country-specific network of referring physicians across various therapeutic areas, playing a key role in ensuring a smooth and effective referral process between referring physicians and study investigators. This is a Home-based position in the United States.
As a Clinical Study Lead, you will oversee vendors for adherence to budget, timelines, and organizational objectives, develop strong vendor and site relationships, and maintain an in-depth understanding of the study protocol. You will coordinate tasks, review monitoring reports, and support financial management and risk management initiatives. This role also involves audit support, maintaining clinical trial registry entries, and mentoring junior team members.
Lead the charge in advancing groundbreaking treatments for preeclampsia and acute ischemic stroke. Oversee clinical trials from conception to completion, ensuring compliance with regulatory standards and best practices. Mentor a team of CRAs, manage resources, and collaborate with key stakeholders, including Project Leaders and Regulatory teams. Guide CRAs, recruit new talent, and manage budgets and vendor relationships.
As a Principal CRA, you will be joining the world’s largest & most comprehensive clinical research organisation. Responsibilities include study specific training, developing and updating monitoring tools, contributing to study monitoring updates, site visits, trip report review, document management, issue escalation, and data facilitation. It is a Lead CRA position with partial project management.