Clinical Trial Associate - MedTech

MCRA, an IQVIA business; United States; Hybrid; USD 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

MCRA, an IQVIA business, is seeking a Clinical Trial Associate to support start-up, execution and closing activities. The role collaborates with the In-House CRA and Clinical Trial Manager to maintain essential documents and regulatory files, and to track monitoring visits and enrollment.

This position is hybrid, requiring 2-3 days in our Washington, DC office, with opportunities to contribute to quality initiatives, TMF/ISF management, and cross-functional project support within a fast-paced

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

• Update and maintain clinical systems that track site compliance and performance within project timelines.
• Maintain Trial Master File (TMF) for multiple studies, including 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 internal quality audits and tracking of internal CAPAs 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