What are the responsibilities and job description for the Clinical Research Coordinator - Pulmonology position at Healthcare Business Associates?
Job Overview
We are seeking a dynamic and detail-oriented Clinical Research Coordinator specializing in Pulmonology to join our innovative research team. In this vital role, you will oversee the planning, execution, and management of clinical trials focused on respiratory health and lung diseases. Your energetic approach will ensure compliance with regulatory standards, facilitate patient engagement, and drive the success of groundbreaking pulmonary research initiatives. This position offers an exciting opportunity to contribute to advancements in respiratory medicine while working within a collaborative and supportive environment.
Duties
- Coordinate all aspects of pulmonary clinical trials, including participant recruitment, scheduling, and follow-up care.
- Ensure adherence to FDA regulations, ICH GCP guidelines, and institutional policies throughout all phases of research.
- Manage data collection, entry, and review using electronic medical record (EMR) systems and clinical data management software aligned with CDISC standards.
- Monitor patient vital signs, blood sampling procedures, and overall health status during trial participation to ensure safety and protocol compliance.
- Review medical documentation such as consent forms, medical histories, and laboratory reports for accuracy and completeness.
- Supervise research staff and collaborate with multidisciplinary teams including nurses, laboratory technicians, and physicians to optimize trial workflows.
- Conduct clinical laboratory procedures such as phlebotomy and blood sampling while maintaining strict compliance with HIPAA privacy regulations.
- Analyze trial data using statistical software tools to support research findings and prepare detailed reports for regulatory submissions.
- Oversee documentation review processes to ensure all trial records meet regulatory standards and audit requirements.
- Facilitate patient monitoring by tracking vital signs, adverse events, and protocol adherence throughout the study duration.
Experience
- Proven supervising experience in clinical research settings with a focus on pulmonology or respiratory studies.
- Extensive background managing clinical trials from initiation through closeout phases.
- Strong knowledge of medical terminology related to pulmonary health and clinical laboratory procedures such as blood sampling.
- Demonstrated expertise in data management systems, EMR platforms, and statistical analysis software used in clinical research environments.
- Familiarity with FDA regulations, ICH GCP standards, HIPAA privacy rules, and CDISC data standards is essential.
- Experience reviewing complex medical documentation including lab results, patient records, and protocol compliance documents.
- Certification in Good Clinical Practice (GCP) from a recognized issuer is required; an ICH GCP certificate is preferred for this role.
- Background in nursing or phlebotomy is advantageous for hands-on patient monitoring tasks.
- Strong analysis skills combined with meticulous attention to detail to ensure high-quality data collection and reporting. Join us in advancing pulmonary health through innovative research! This role offers an energetic environment where your expertise will directly impact patient outcomes while supporting your professional growth in clinical development and regulatory compliance.
Pay: From $50,000.00 per year
Work Location: In person
Salary : $50,000