Clinical Research Associate (Req Exp in Medical Device and Veeva Vault)

millenniumsoft • Irvine, CA

7d • Remote

About The Position

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
• Veeva experience or like platform
• Clinical research experience
• Data collections
• Medical Device experience
• US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

Nice To Haves

• Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)

Responsibilities

• 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

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level