Experienced CRA - Real World Evidence with SSU experience

• 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.

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, 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

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

, ensuring timely follow-up of open actions and study milestones.

• Collaborate and liaise closely with study team members,

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.

•

, including experience with essential document collection, regulatory/ethics submissions, site activation and follow-up of start-up timelines.

• Previous experience in

would be an advantage.

• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and ICH guidelines, as applicable to assigned studies.
• Good therapeutic and protocol knowledge as provided through company and project-specific training.
• Strong organizational and prioritization skills, with the ability to manage a varied workload across multiple sites and different stages of study execution, particularly start-up and ongoing site management activities .
• Demonstrated ability to work independently and proactively follow up with investigative sites and internal stakeholders.
• Strong problem-solving skills and ability to identify and escalate potential study or site-level risks in a timely manner.
• Computer skills including proficiency in Microsoft Word, Excel and PowerPoint and use of relevant clinical research systems and technology.
• Strong written and verbal communication skills, including good command of the English language.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, investigative sites and clients.