Research Coordinator

Job Overview
We are seeking a dynamic and detail-oriented Research Coordinator to join our innovative research team. In this vital role, you will oversee the planning, execution, and management of clinical research studies, ensuring compliance with regulatory standards and maintaining high-quality data collection. Your energetic approach will drive the success of our clinical trials, support patient safety, and facilitate seamless communication among multidisciplinary teams. This position offers an exciting opportunity to contribute to cutting-edge medical research and improve patient outcomes through meticulous coordination and management.

Responsibilities

• Coordinate all aspects of clinical trials, including participant recruitment, scheduling, and follow-up to ensure timely study progress.
• Manage documentation review processes, ensuring accuracy, completeness, and adherence to regulatory guidelines such as FDA regulations and ICH GCP standards.
• Supervise research staff and collaborate with clinical teams to monitor patient safety, vital signs, blood sampling, and other clinical procedures.
• Oversee data collection, entry, and management using electronic medical record (EMR) systems and adhere to CDISC standards for data consistency.
• Ensure compliance with HIPAA regulations by maintaining confidentiality of patient information and managing documentation securely.
• Review study protocols, consent forms, and regulatory documents to guarantee clarity and compliance before implementation.
• Support statistical analysis by utilizing appropriate software tools to interpret research data accurately.
• Maintain detailed records of clinical laboratory results, blood sampling procedures, and patient monitoring activities in accordance with FDA and ICH GCP guidelines.
• Facilitate training sessions on research protocols, regulatory requirements, and documentation procedures for team members.

Experience

• Proven supervising experience in a clinical research or healthcare setting with demonstrated leadership capabilities.
• Extensive knowledge of clinical trials management including patient monitoring, data collection, and compliance management.
• Strong understanding of medical terminology, blood sampling techniques such as phlebotomy, and clinical laboratory procedures.
• Experience working with EMR systems and familiarity with HIPAA regulations for patient privacy protection.
• Proficiency in statistical software for data analysis coupled with a solid grasp of CDISC standards for clinical data management.
• Knowledge of FDA regulations governing clinical research along with ICH GCP certification from a recognized issuer (e.g., CA).
• Background in nursing or clinical development is highly desirable; experience in blood sampling or phlebotomy is a plus.
• Excellent analysis skills combined with meticulous attention to detail in documentation review and compliance oversight. Join us in advancing medical science through rigorous research coordination! Your expertise will help shape groundbreaking therapies while supporting the highest standards of patient safety and data integrity.

Pay: $40,898.57 - $50,888.59 per year

Work Location: In person