Note: The job is a remote job and is open to candidates in USA. Piper Companies is seeking a detail-oriented and highly organized Clinical Research Associate to support clinical trials. The role is responsible for site monitoring, regulatory compliance, study start-up, documentation, audit readiness, and tracking study progress, with travel across the Southeast and Northeast regions.
Responsibilities
- Conduct site qualification, initiation, routine monitoring, and closeout visits for clinical research studies
- Ensure clinical trials are conducted according to study protocols, GCP guidelines, FDA regulations, and applicable local requirements
- Review source documentation, informed consent forms, and regulatory documents for accuracy and compliance
- Monitor patient recruitment, enrollment, retention, and protocol compliance
- Maintain accurate monitoring reports and study documentation within required
- Assist with study start-up activities, including regulatory submissions and site training
- Support audit and inspection readiness activities
- Track study milestones and provide regular updates on site performance and study progress
Skills
- 4+ years of clinical research experience, preferably as a Clinical Research Associate or on-site monitoring
- CRA certification (ACRP, SOCRA, or equivalent)
- Experience working with electronic data capture (EDC) systems
- Familiarity with risk-based monitoring methodologies
- Knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial processes
- Proficiency with Microsoft Office Suite and Clinical Trial Management Systems (CTMS)
- Ability to travel up to 50% as required
- Bachelor's degree in Life Sciences, Biology, Nursing, Public Health, or a related field
- Experience monitoring Phase I-IV clinical trials
- Experience in oncology, immunology, cardiology, neuroscience, or rare disease studies
Benefits
- Medical
- Dental
- Vision
- 401k
- Sick leave required as by law
- PTO
- Holidays
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