Experienced CRA - Real World Evidence with SSU experience

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.