Hybrid CRA: Site Management & Regulatory Focus

ZP Group; Bethesda (MD); Hybrid; USD 50,000 - 70,000; Full time

Benefits offered by this job

Medical, Dental, Vision (through Cigna

401k

Sick leave

PTO

Paid Holidays

Job summary

Piper Companies is seeking a Clinical Research Associate (CRA) to support the operational delivery of clinical trials across infectious disease, oncology, and cardiology programs. This hybrid role is based in Bethesda, MD and acts as a key liaison between investigative sites and study teams, driving site performance, regulatory compliance, and data quality.

This role requires 2-5+ years of clinical research experience and strong knowledge of ICH-GCP and FDA regulations.

Qualifications

• 2–5+ years of clinical research experience (CRO, sponsor, or site) in-house 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.

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.

Skills

Regulatory knowledge

Trial processes

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences Nursing Public Health or related field

Tools

eTMF

CTMS

EDC systems

Job description

Piper Companies is seeking a Clinical Research Associate (CRA) to support the operational delivery of clinical trials across infectious disease, oncology, and cardiology programs. This hybrid role is based in Bethesda, MD and acts as a key liaison between investigative sites and study teams, driving site performance, regulatory compliance, and data quality.

This role requires 2-5+ years of clinical research experience and strong knowledge of ICH-GCP and FDA regulations.