CRA II: Global Clinical Operations (Remote/Hybrid)

Emerald Clinical Trials Inc.; North Carolina; Hybrid; USD 110,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation

Hybrid or remote working options

Career growth opportunities

Employee wellbeing programs

Global opportunities

Job summary

Emerald Clinical Trials Inc. is seeking a Clinical Research Associate 2 (CRA2) to join our Clinical Operations team. You will manage sites, monitor trials, ensure regulatory compliance, and support startup tasks across multiple studies.

Experience in CRO/pharma environments and strong communication are essential. You will coordinate budgets, contracts, regulatory packages, and TMF maintenance while training site personnel and driving patient recruitment efforts.

Qualifications

• 2–5 years on-site monitoring and site management experience mandatory.
• Experience in academic, CRO, or pharmaceutical settings preferred.
• Solid knowledge of ethical and regulatory research requirements (ICH-GCP).
• Strong communication, negotiation and organizational skills.
• Willingness and ability to travel as required.

Responsibilities

• Identify, assess feasibility, and select investigators and sites for trials.
• Perform monitoring visits per the Monitoring Plan and write reports on time.
• Conduct site evaluation visits and report outcomes for site selection.
• Coordinate regulatory packaging with colleagues and ethics submissions.
• Negotiate site budgets and track contract execution and payments.
• Lead site initiation visits and prepare start-up documentation.
• Develop and maintain monitoring tools and trial documents.
• Train and motivate site staff on protocol, product, and trial requirements.
• Review TMF contents and reconcile with site files.
• Coordinate distribution and handling of investigational products and supplies.
• Maintain data in CTMS and other trial-tracking systems.
• Support strategies to boost recruitment efforts.

Skills

ICH-GCP knowledge

Site management

Monitoring experience

Negotiation

Communication skills

Travel availability

Education

Science/Healthcare degree

Job description

Emerald Clinical Trials Inc. is seeking a Clinical Research Associate 2 (CRA2) to join our Clinical Operations team. You will manage sites, monitor trials, ensure regulatory compliance, and support startup tasks across multiple studies.

Experience in CRO/pharma environments and strong communication are essential. You will coordinate budgets, contracts, regulatory packages, and TMF maintenance while training site personnel and driving patient recruitment efforts.