Clinical Research Associate (Hybrid)

Responsibilities

• Lead site management support activities, including remote monitoring, site communication, and performance tracking to ensure enrollment, compliance, and milestone adherence.
• Drive regulatory and document control processes by maintaining eTMF completeness, reviewing essential documents, and ensuring inspection readiness at all times.
• Ensure data quality and integrity through proactive EDC review, query management, and identification/escalation of protocol deviations or risks.
• Support full clinical trial lifecycle execution, including site start-up, activation, maintenance, and closeout in alignment with study timelines.
• Collaborate cross-functionally with CRAs, CTMs, QA, and Data Management teams to resolve issues, mitigate risks, and maintain compliance with ICH-GCP and SOPs.

Qualifications

• 2-5+ years of clinical research experience (CRO, sponsor, or site), in-house preferred
• Prior experience in in-house CRA, CTA, or site management role preferred
• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes
• Experience with eTMF, CTMS, and EDC systems
• Solid understanding of document control, audit readiness, and ALCOA+ principles
• Exposure to infectious disease, oncology, or cardiology trials
• Bachelor’s degree in Life Sciences, Nursing, Public Health, or related field

Compensation

Salary: $50,000 - $70,000 annually, commensurate with experience
Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO (Paid Time Off), Paid Holidays

Benefits

• Medical
• Dental
• Vision (through Cigna)
• 401k
• Sick leave required as by law
• PTO (Paid Time Off)
• Paid Holidays