A Clinical Coordinator coordinates operations and oversees medical assisting staff in a clinic or medical department. Responsibilities include supervision of day-to-day operations, management of business aspects, HR duties within the team.
Job Overview We are seeking medical students or people with a background in clinical researh or who would like to gain experience in clinical research who are dedicated and detail-oriented Clinical Study Coordinator and Assistant to support the successful execution of clinical research projects. We are willing to train individuals who have the skillset to pickup and learn quickly who can retain and implement the assigned task. The ideal candidate will possess a strong foundation in clinical research methods, healthcare compliance, and project management, with the ability to coordinate multiple aspects of clinical trials efficiently.
Assistant Clinical Research Coordinator Qualifications:
Strong background in Ophthalmology or vision related clinical studies strong knowledge of IRB processes, GCP guidelines and regulatory compliance some knowledge of phlebotomy knowledge of electronic data entry and regulatory binders excellent attention to detail and communication skills knowledge excel is a plus Responsible for: Supporting patient enrollment and study visits maintain accurate study documentation, data entry, some labs and regulatory binders conduct patient recruitment, screening, informed consent, and study visits, including testing prepare, submit, and maintain IRB applications, amendments.
summary:
We need an experienced Clinical Research Coordinator with a strong background in ophthalmic studies and regulatory compliance. The ideal candidate will manage day-to-day research operations, ensure adherence toIRB requirements, and support investigators in the execution of clinical trials focused on eye health. In addition,the candidate will assist the Clinical Manager with day to day operations. This role offers an opportunity to contribute to advancing medical knowledge while working within a dynamic research environment that emphasizes quality, ethical standards, and regulatory adherence. The position is paid and requires a proactive approach to ensure the integrity and success of each study. Other Responsibilities Coordinate all phases of clinical trials, including patient recruitment, scheduling, and follow-up to ensure adherence to study protocols. Review and verify documentation for accuracy, completeness, and compliance with regulatory standards such as FDA regulations, ICH GCP guidelines, and HIPAA requirements. Monitor patient progress by collecting results and recording clinical data accurately within electronic medical record (EMR) systems. Assist in maintaining regulatory documentation, ensuring proper filing and review processes are followed for audit readiness. Support clinical laboratory activities by understanding sample handling procedures, analysis skills, and laboratory safety protocols. Collaborate with multidisciplinary teams to ensure research project milestones are met on time while maintaining high standards of clinical quality assurance. Manage data collection processes using statistical software and CDISC standards to facilitate accurate data management and analysis. Ensure compliance with healthcare regulations, clinical ethical guidelines, and research project management protocols throughout all phases of the trial. Supervise junior staff or volunteers involved in research activities, fostering a collaborative team environment that promotes continuous improvement. Requirements Medical student with some experience in clinical research settings with familiarity in clinical trials management and healthcare compliance standards. Some knowledge of medical terminology, clinical development processes, and regulatory requirements such as FDA regulations and ICH guidelines. Proficiency in Microsoft Office applications, EMR systems, statistical software, and data management tools. Desirable but willing to train. Experience with clinical laboratory procedures including blood sampling (phlebotomy), vital signs measurement, and sample processing. Excellent organizational skills with the ability to review complex documentation thoroughly and manage multiple projects simultaneously. Background in healthcare-related fields is advantageous; familiarity with clinical research methods and project management experience in healthcare is preferred. Join us in advancing innovative medical research by ensuring meticulous coordination of clinical studies that uphold the highest standards of integrity and participant safety!
