Hybrid CRA: Site Lead for Infectious Disease Trials

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

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 role serves as a key liaison between investigative sites and study teams, driving site performance, regulatory compliance, and data quality.

Hybrid work arrangement based in Bethesda, MD. Responsibilities include site management, regulatory documentation (eTMF), data quality via EDC, and lifecycle support from

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.

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

Clinical research experience

ICH-GCP knowledge

FDA regulations

eTMF experience

CTMS experience

EDC systems

Audit readiness

ALCOA+ principles

Education

Life Sciences degree

Tools

eTMF

CTMS

EDC

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 role serves as a key liaison between investigative sites and study teams, driving site performance, regulatory compliance, and data quality.

Hybrid work arrangement based in Bethesda, MD. Responsibilities include site management, regulatory documentation (eTMF), data quality via EDC, and lifecycle support from