Clinical Research Coordinator
4 hours ago
Overview
The Clinical Research Coordinator (CRC) supports the execution of clinical trials focused on asthma, allergic rhinitis, food allergies, eczema, and other immunologic conditions. The CRC works under the direction of the Principal Investigator (PI) and Site Director and is responsible for coordinating all aspects of assigned clinical studies, ensuring compliance with study protocols, GCP guidelines, and site SOPs.
Our research team has an average of 10+ years of experience and a fully dedicated marketing team and regulatory team. We operate with the agility and excitement of a startup, while grounded in years of operational excellence. We are looking for someone who is eager to grow with our team, contribute ideas, and help shape the future of our research program.
Responsibilities
- Coordinate and manage all aspects of clinical trials, including participant recruitment, screening, and enrollment.
- Ensure compliance with HIPAA regulations and maintain confidentiality of patient information.
- Oversee data management processes to ensure accuracy and integrity of research data.
- Supervise research staff and provide training on protocols and procedures.
- Collaborate with clinical laboratories to facilitate sample collection and processing.
- Conduct phlebotomy as needed for sample collection during trials.
- Monitor study progress and ensure adherence to study timelines and protocols.
- Maintain documentation related to compliance management and regulatory standards.
- Administer and monitor investigational products (e.g., inhalers, injectables, oral therapies) as permitted
- Monitor for and report adverse events
- Track enrollment, visit windows, deviations, and protocol adherence
- Respond to queries in EDC systems and assist in resolving data issues
Skills
- Strong understanding of HIPAA regulations and compliance requirements.
- Bachelor's degree in health sciences, life sciences, nursing, or related field
- Minimum of 2 years of experience in clinical research (asthma/allergy experience preferred)
- Familiarity with respiratory assessments (e.g., spirometry, FeNO) and allergy testing is highly desirable
- Knowledge of FDA regulations, ICH-GCP guidelines, and clinical research operations
- BLS certification required; phlebotomy or MA certification a plus
- Excellent attention to detail, communication, and organizational skills
- Proficiency in Microsoft Office and EDC platforms (e.g., Medidata, Veeva, Rave)
- Preference for bilingual staff given the diverse population
This role is essential for advancing medical knowledge through rigorous research practices while ensuring participant safety and ethical standards are upheld throughout the study process.
Job Type: Full-time
Pay: $ $38.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Experience:
- Clinical Research Coordinator: 5 years (Preferred)
Work Location: In person
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