Clinical Trial Associate

IQVIA; Washington (District of Columbia); Hybrid; USD 49,000 - 123,000; Full time

Job summary

IQVIA MedTech, part of IQVIA, is seeking a Clinical Trial Associate to support the In-House CRA and Clinical Trial Manager with essential documents, regulatory tracking, and start-up activities. This hybrid role is based in Washington, DC, with 2-3 days in the office.

You will maintain TMF, ISF binders, and trial supplies, assist with quality audits and CAPAs, and help build strong relationships with site staff and project teams.

Qualifications

• Bachelor's degree in a scientific, management or related discipline.
• 1-2 years of experience in an office environment.
• Proficiency with MS Office applications.
• Demonstrated professional oral and written communication.

Responsibilities

• Support clinical project team by updating and maintaining clinical systems that track site compliance and performance within project timelines.
• Maintain Trial Master File (TMF) for multiple studies, including supporting periodic review of study files for accuracy and completeness.
• File, track and archive TMF documentation and reports.
• Create Investigator Site File (ISF) binders and patient binders for site use.
• Handle, distribute and track clinical trial supplies (non-IP) for site use.
• Support in-house CRA in documentation of all training sessions and/or meeting minutes as needed.
• Assist Clinical Affairs and Clinical Quality Assurance teams with preparation for internal quality audits and tracking of internal CAPAs (Corrective and Preventative Actions) as part of quality management reviews.
• Develop and maintain positive relationships both internal and external to projects, including clients, team members, and site personnel (PIs, Study coordinators, etc.).

Skills

Communication skills

Education

Bachelor's degree in a scientific, management or related discipline

Tools

MS Office

Job description

MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner, IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together, we support innovation from concept to commercialization, offering expertise in regulatory strategy, clinical trial design and execution, market access, and post-market optimization. Our teams combine deep therapeutic knowledge with advanced data and technology to help clients make smarter decisions and thrive in the market. Join our team to help shape the future of MedTech.

Position Overview

The Clinical Trial Associate (CTA) supports the In-House Clinical Research Associate and clinical Trial Manager to ensure optimal management of essential documents with logistical and administrative tasks related to clinical trial start-up, execution and closing. The CTA supports regulatory document collection and tracking of monitoring visits and enrollment at the study-level. Responsible for completion of administrative tasks relating to implementing quality initiatives and the quality management system as applicable. This position is hybrid (2-3 days in office) out of our Washington, DC office.

Responsibilities

• Support clinical project team by updating and maintaining clinical systems that track site compliance and performance within project timelines.
• Maintain Trial Master File (TMF) for multiple studies, including supporting periodic review of study files for accuracy and completeness.
• File, track and archive TMF documentation and reports.
• Create Investigator Site File (ISF) binders and patient binders for site use.
• Handle, distribute and track clinical trial supplies (non-IP) for site use.
• Support in-house CRA in documentation of all training sessions and/or meeting minutes as needed.
• Assist Clinical Affairs and Clinical Quality Assurance teams with preparation for internal quality audits and tracking of internal CAPAs (Corrective and Preventative Actions) as part of quality management reviews.
• Develop and maintain positive relationships both internal and external to projects, including clients, team members, and site personnel (PIs, Study coordinators, etc.).

Required Qualifications

• Bachelor's degree in a scientific, management or related discipline.
• 1-2 years of experience in an office environment.
• Proficiency with MS Office applications.
• Demonstrated professional oral and written communication

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

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.

The potential base pay range for this role, when annualized, is $49,200.00 - $123,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.