Experienced CRA - SSU

Perform monitoring, site management and Site Start-Up (SSU) activities for Real World Evidence (RWE) studies, ensuring that sites conduct studies and report study data in accordance with the study protocol, applicable regulations and guidelines, and sponsor requirements.

The role combines traditional CRA responsibilities with a strong focus on site activation, regulatory and start-up activities
. Due to the nature of RWE studies, the position may involve a reduced number of on-site monitoring visits compared with CRA roles supporting traditional interventional or early-phase clinical trials
. However, this is balanced by frequent SSU activities, remote site management, regulatory follow-up and coordination across multiple sites , requiring strong organization, prioritization and ownership of a challenging and dynamic workload.

• Perform site monitoring visits, including selection, initiation, monitoring and close-out visits, as required by the study and in accordance with contracted scope of work, applicable regulatory requirements, Good Clinical Practice (GCP), ICH guidelines and sponsor requirements.
• Perform and coordinate Site Start-Up activities , including collection and review of essential documents, preparation and follow-up of regulatory and ethics submissions, site activation activities and ongoing communication with investigative sites.
• Drive sites through the start-up process , proactively identifying potential delays, following up on outstanding documentation and working with internal and external stakeholders to achieve study timelines.
• Manage multiple sites and priorities simultaneously, balancing SSU, monitoring and ongoing site management responsibilities throughout the study lifecycle.
• Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations, milestones and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory and ethics submissions and approvals, site activation, recruitment and enrollment, CRF completion and submission, and data query generation and resolution , as applicable to the study.
• Ensure copies/originals, as required, of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with applicable regulatory and study requirements.
• Create and maintain appropriate documentation regarding site management, monitoring activities, visit findings and action plans by submitting regular reports, generating follow-up communications and completing other required study documentation.
• Maintain regular remote oversight and communication with assigned sites , ensuring timely follow-up of open actions and study milestones.
• Collaborate and liaise closely with study team members,
  Site Start-Up colleagues, regulatory teams, project management and other functional stakeholders to support successful project execution.
• If applicable, support development of project subject recruitment plans on a per-site basis.
• If applicable, support site financial management according to executed clinical trial agreements and retrieve invoices according to local requirements.

• Bachelor’s Degree in a scientific discipline, healthcare or related field preferred.
• At least 1 year of independent…