Clinical Research Coordinator

Clinical Research Coordinator - Lake Success, NY

Northwell Health, a premier healthcare provider in New York, is seeking a dedicated Clinical Research Coordinator to join our team in Lake Success, NY. This pivotal role involves the comprehensive oversight of clinical research trials, including participant recruitment, study coordination, and ensuring strict adherence to all protocols and regulatory requirements. You will be instrumental in maintaining accurate and up-to-date study records, processing biological specimens, and collaborating effectively with physicians, investigators, healthcare providers, and external agencies.

Key Responsibilities:

• Spearhead the coordination of assigned research studies or groups of studies.
• Manage subject recruitment, implement study procedures, and oversee data collection and processing for research projects.
• Maintain meticulous and current study documentation.
• Collect, label, log, process, and ship biological specimens for analysis in compliance with protocols and training.
• Schedule study participants for protocol-related evaluations.
• Foster respectful collaboration with physicians, investigators, and other healthcare professionals, prioritizing participant rights.
• Administer, score, and evaluate assessments as assigned and per study protocol; collect data, consult with the Principal Investigator (PI), and submit results to sponsors.
• Liaise with external agencies, including FDA, pharmaceutical companies, laboratories, and equipment/supply vendors.
• Organize and manage all phases of the grant application process for submission to funding agencies.
• Ensure the availability of study drug supplies and/or equipment, and maintain drug accountability logs.
• Uphold Good Clinical Practice (GCP) standards and ensure compliance with all regulatory and grant agency requirements.
• Follow study protocols meticulously and keep the investigator or supervisor informed of all developments.
• Collaborate with the PI, FDA, and pharmaceutical companies on study-related matters.
• May be required to perform phlebotomy, electrocardiograms, or monitor vital signs, reporting findings to the supervisor.
• Operate with general guidance, handling varied assignments that require interpretation and independent decision-making.
• Perform other related duties as required.

All responsibilities listed are considered essential functions of this role.