Contract Senior CRA — Remote/Onsite Monitoring Lead

11 Premier Research International LLC; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Premier Research is seeking a Senior Clinical Research Associate (Contract) to join our Clinical Monitoring, Site Management and SSU team. This role supports biotech, medtech, and specialty pharma clients, helping to translate science into new medicines, devices and diagnostics.

You will monitor data integrity and subject safety in line with ICH-GCP/ISO14155, plan monitoring activities, and collaborate with Clinical Leads to optimize site visits.

Qualifications

• Undergraduate degree in clinical, science, or health-related field or licensed health-care professional.
• Knowledge of ICH-GCP/ISO14155, FDA guidance and EU directives.
• Experience coordinating and monitoring clinical studies.

Responsibilities

• Delivers quality, timely monitoring reports for sponsor approval per CMP timelines.
• Ensures validity and completeness of clinical data as per protocol and client requirements.
• Monitors by remote, on-site or approved mode focusing on data integrity and patient safety.
• Plans day-to-day monitoring activities and sets site priorities.
• Prepares and conducts site qualification, initiation, interim monitoring, dosing observation, and close-out visits per CMP.

Skills

Monitoring experience

ICH-GCP knowledge

FDA/EU regulatory knowledge

Data integrity

Multitasking

Travel willingness

Clinical monitoring

Education

Undergraduate degree in clinical/science/health

Licensed healthcare professional (RN or equivalent)

Tools

EDC systems

Job description

Premier Research is seeking a Senior Clinical Research Associate (Contract) to join our Clinical Monitoring, Site Management and SSU team. This role supports biotech, medtech, and specialty pharma clients, helping to translate science into new medicines, devices and diagnostics.

You will monitor data integrity and subject safety in line with ICH-GCP/ISO14155, plan monitoring activities, and collaborate with Clinical Leads to optimize site visits.