Experienced CRA - Real World Evidence with SSU experience

RWE Clinical Research Associate (CRA) with Site Start-Up Experience

Job Overview

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.

Essential Functions

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.

Qualifications

Bachelor's Degree in a scientific discipline, healthcare or related field preferred.

At least 1 year of independent on-site monitoring experience required.

Previous experience with Site Start-Up activities is strongly preferred, including experience with essential document collection, regulatory/ethics submissions, site activation and follow-up of start-up timelines.

Previous experience in Real World Evidence (RWE), observational, non-interventional, registry or post-authorization studies 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.

What to Expect in This Role

This RWE CRA position offers a different balance of responsibilities from a traditional early-phase CRA role. While the number and frequency of on-site monitoring visits may be lower depending on study design and project requirements, the role has a significant Site Start-Up and site management component.

Successful candidates should therefore be comfortable managing frequent site activations, regulatory documentation and follow-up, remote site interactions and multiple concurrent priorities. The position is particularly suited to CRAs who enjoy taking ownership of sites throughout the study lifecycle and who combine solid monitoring experience with strong SSU and organizational capabilities.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.