Job Overview
We are seeking a dedicated and highly organized Clinical Study Coordinator specialized in Hematology to join our research team. The ideal candidate will possess a comprehensive understanding of clinical trials management, patient care, and regulatory compliance within hematology research settings. As a Clinical Study Coordinator, you will oversee the coordination and execution of clinical studies focused on blood disorders and hematologic conditions, ensuring adherence to ethical standards, regulatory requirements, and study protocols. This role offers an opportunity to contribute significantly to advancing medical knowledge and patient care through meticulous research management.
Responsibilities
- Coordinate all aspects of hematology-focused clinical trials, including participant recruitment, enrollment, and follow-up.
- Monitor patient progress throughout the study, ensuring safety and adherence to protocol guidelines.
- Review and verify clinical documentation for accuracy, completeness, and compliance with FDA regulations and ICH GCP standards.
- Manage data collection processes utilizing EMR (Electronic Medical Record) systems and ensure data integrity in accordance with CDISC standards.
- Conduct blood sampling and phlebotomy procedures with precision while maintaining patient comfort and safety.
- Collaborate with clinical laboratories to process samples accurately and timely for analysis.
- Ensure compliance with healthcare regulations such as HIPAA and healthcare ethical guidelines during all study activities.
- Supervise junior staff or research assistants involved in data management, patient monitoring, or laboratory procedures.
Requirements
- Proven experience in clinical trials management within a research or healthcare setting, particularly in hematology or related fields.
- Supervising experience in a clinical environment is highly desirable.
- Strong knowledge of medical terminology, blood sampling techniques, and clinical laboratory procedures.
- Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance, and healthcare ethical standards.
- Proficiency in data management software, statistical analysis tools, and EMR systems.
- Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent is required; ICH GCP certification preferred.
- Experience with project management in healthcare or research project oversight is advantageous.
- Excellent organizational skills with attention to detail for documentation review and data collection processes.
- Ability to work effectively within multidisciplinary teams while maintaining high standards of compliance and quality assurance.
Join our team to advance hematology research through meticulous coordination, innovative study management, and unwavering commitment to ethical standards!
Pay: $50,000.00 - $60,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Tuition reimbursement
- Vision insurance
Work Location: In person
