In-House CRA

IQVIA•Washington, DC

About The Position

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 In-House Clinical Research Associate/ MedTech Site Manager 1 will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm’s clientele. Responsible for management of investigator site and Clinical Research Associate (CRA) activities for assigned studies. The In-House CRA will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

Requirements

Bachelor’s degree (B.A./B.S.) in pharmacy, pharmaceutics or a related scientific discipline
2+ years of clinical trial experience.
Monitoring experience preferred.
Comprehensive knowledge/ fluency of GCPs and clinical monitoring procedures
Understanding of therapeutic area for assigned clinical projects.
Experience using Electronic Data Capture (EDC) and clinical trial management systems.
Possesses strong written and verbal communication and presentation skills.
Strong research, analytical, critical-thinking and problem solving skills
PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus)

Responsibilities

Review and approve research and study regulatory documents required for the implementation, monitoring, and evaluation of clinical trials.
Review clinical protocols to ensure collection of data needed for regulatory submissions
Contribute to protocol-specific manuals, plans, and documents as needed.
Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan.
Assist project manager with clinical study planning and management, as required.
Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.).
Assist in the identification and recruitment of potential investigators and study sites, as needed.
Ensure Trial Master File is accurate and complete throughout the lifecycle of the project.
Assist with site training for assigned clinical trials.
Assist with site audits and site quality management activities as needed.
Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas.