Clinical Research Coordinator

Clinical Research Coordinator Womens' Pelvic Surgery of North Jersey Hackensack, NJ Job Details Part-time | Full-time $23 - $28 an hour 1 day ago Qualifications Statistical software Statistics Teamwork Clinical research Electronic health records (EHR) management Scientific research

HIPAA ICH

guidelines Data entry Organizational skills Research regulatory compliance Medical terminology FDA regulations Statistical analysis tools Full Job Description Job Overview We are seeking a dedicated and detail-oriented Clinical Research Coordinator to oversee and facilitate clinical data within our research programs. The ideal candidate will possess a strong background in clinical research management, patient monitoring, and regulatory compliance. As a vital member of our team, the Clinical Research Coordinator will ensure the integrity of study data, adherence to protocols, and compliance with all applicable regulations, including FDA guidelines and ICH Good Clinical Practice standards. This role offers an opportunity to contribute to groundbreaking medical research while supporting patient safety and data accuracy. Responsibilities Coordinate and manage all aspects of clinical trials, including participant recruitment, enrollment, and retention. Review and verify study documentation for accuracy, completeness, and regulatory compliance. Monitor patient progress throughout the trial, including vital signs, blood sampling, and adverse event reporting. Ensure adherence to protocol procedures, FDA regulations, HIPAA privacy standards, and ICH GCP guidelines. Maintain detailed records within electronic medical record (EMR) systems and clinical trial management software. Supervise research staff and collaborate with multidisciplinary teams to ensure smooth trial operations. Conduct data collection, entry, and management in accordance with CDISC standards for data interoperability. Oversee laboratory procedures such as blood sampling and phlebotomy while maintaining clinical laboratory standards. Prepare reports for regulatory submissions and audit readiness by reviewing documentation meticulously. Facilitate training sessions on clinical trial protocols, compliance requirements, and safety procedures. Requirements Proven experience supervising clinical research teams or managing clinical trials from initiation to completion. Strong knowledge of clinical trials management, including FDA regulations, ICH GCP standards, and HIPAA compliance. Proficiency in medical terminology, data management software, statistical analysis tools, and EMR systems. Familiarity with clinical development processes across various therapeutic areas. Certification in ICH GCP or equivalent (e.g., CA certification from a recognized issuer) is required. Excellent organizational skills with meticulous attention to detail in documentation review and data collection. Ability to analyze complex data sets using statistical software to support research findings. Strong interpersonal skills for patient monitoring, staff supervision, and multidisciplinary collaboration. Join us in advancing medical science through rigorous research coordination that ensures safety, compliance, and high-quality data collection for impactful healthcare innovations!

Pay:

$23.00 - $28.00 per hour

Work Location:

Hybrid remote in Hackensack, NJ 07601