Job Summary
We are seeking a dynamic and detail-oriented Research Coordinator to join our clinical research team. In this vital role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and maintaining the highest quality of data collection. Your expertise will facilitate smooth study operations, support patient safety, and contribute to groundbreaking medical advancements. This paid position offers an exciting opportunity to be at the forefront of clinical research, working closely with multidisciplinary teams to drive innovative health solutions forward.
Responsibilities
- Coordinate all aspects of clinical trial activities, including participant recruitment, scheduling, and follow-up.
- Manage documentation review to ensure accuracy, completeness, and adherence to protocol requirements.
- Monitor patient progress by collecting vital signs, blood samples through phlebotomy, and tracking clinical data in electronic medical records (EMR) systems.
- Supervise research staff and volunteers, providing guidance on clinical procedures and compliance management.
- Ensure all activities comply with FDA regulations, ICH GCP guidelines, HIPAA privacy standards, and CDISC data standards.
- Oversee data collection processes and utilize statistical software for preliminary analysis to support study integrity.
- Maintain meticulous records of study activities, adverse events, and protocol deviations for audit readiness.
Qualifications
- Proven supervising experience in a clinical or research setting.
- Strong knowledge of clinical trials management, including patient monitoring and data management protocols.
- Familiarity with medical terminology, blood sampling techniques such as phlebotomy, and vital signs measurement.
- Experience working with EMR systems and understanding of HIPAA compliance requirements.
- Certification in Good Clinical Practice (GCP) from a recognized issuer; ICH GCP certification preferred.
- Knowledge of FDA regulations related to clinical development and trial conduct.
- Background in clinical laboratory procedures or nursing is highly advantageous.
- Proficiency with statistical software tools used for data analysis in research settings. Join us to contribute meaningfully to health innovation while advancing your career in a fast-paced, collaborative environment committed to excellence!
Pay: $18.00 - $20.00 per hour
Work Location: In person