Clinical Research Associate, Medical Device, Veeva Vault

🔥 2 hours ago

🏄 California – Remote

🏄 California – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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MillenniumSoft Inc

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1999

🎯 Recruiter

🤝 B2B

Recruitment • B2B

MillenniumSoft Inc. is a Virginia-based staffing and recruiting firm that provides end-to-end (360-degree) human resources solutions to enterprise and government clients. The company offers contingent/temporary staffing, direct placement of professionals and consultants, in-house HR services, specialized staffing/consulting, and staffing for IT support and application development roles. MillenniumSoft also lists services in quality assurance, project and program management, ERP/CRM implementations, database administration, infrastructure and security maintenance, and other IT-related placements. It serves multiple verticals including communications, manufacturing/mobile application development, IT, financial services, energy, medical devices, healthcare/pharmaceuticals, and media/entertainment; has federal and state government contracting experience; and is E-Verified and WBE-certified in Virginia.

📋 Description

• Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements. • Provide cross functional operational support throughout the study lifecycle, investigating data or documentation discrepancies and contributing to process improvements that reduce recurrence during study conduct and closeout • Support and coordinate study start up activities, including tracking site readiness, managing essential document collection, and communicating with sites regarding planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs). • Perform remote monitoring visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study monitoring plan • Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel • Build and maintain strong working relationships with internal partners (Clinical Operations, Regulatory Affairs, Quality, R&D) and site personnel (Investigators, CRCs, research nurses) to support enrollment, data quality, and site performance. • Assist with any site remediation activities, as applicable • Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training • Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas

🎯 Requirements

• Bachelor's Degree or Equivalent Life Sciences or Nursing • 3-4 years in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry • Experience with electronic data capture. • Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)

🏖️ Benefits

• REMOTE • Flexible working hours