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 (CRA) to support the planning, execution, monitoring, and closeout of clinical trials. The CRA is responsible for ensuring clinical trials are conducted according to established protocols and regulations, while also conducting site visits and maintaining accurate study documentation.
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 in oncology, immunology, cardiology, neuroscience, or rare disease studies
- 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
Benefits
- Medical
- Dental
- Vision
- 401k
- Sick leave required as by law
- PTO
- Holidays
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