Hybrid Clinical Trial Operations Associate

MCRA, an IQVIA business; United States; Hybride; USD 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

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.

Responsabilités

• 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.).

Connaissances

Communication skills

Formation

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

Outils

MS Office

Description du poste

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