The Project Manager/Clinical Research Coordinator manages all aspects of the clinical research studies, oversees the running of several clinical trials, manages the day to day operations of the clinic, coordinators and subjects, as well as interfacing with the Sponsor and the PI.
Develops, coordinates, and reviews research study procedures to ensure receipt, completeness, and accuracy of research data required for studies.
Directs conduct of research studies to ensure adherence to protocol and provides updates to PI and management team as needed.
Coordinates all regulatory aspects, such as preparing regulatory packets, safety reports, adverse events.
Develops procedures to determine subject eligibility; screens, recruits, and enrolls subjects, ensuring and documenting or all aspects of such.
Coordinates collection of all trial data and completes Case Report Forms
Prepares IRB submission documents and informs IRB of amendments to research studies; SAEs, or Unanticipated Problems as needed.
Oversees drug accountability and maintains drug accountability.
Maintains research office functionality and requirements for study equipment calibration.
Recognizes and repairs areas of deficiency
Game plan study conduct and recruitment of subjects.
Assist in identifying talent.
Scheduling of staff, including investigators and research assistants.
Bachelor's degree or higher in a healthcare or clinical research related field
Minimum of three (3) years clinical research experience
Certified Clinical Research Coordinator (CCRC) preferred
Solid understanding of GCP/ICH requirements and FDA regulations
Proficient in Microsoft Office
Ability to organize a high-volume workload and prioritize tasks accordingly
Strong work ethics, team player and manager with a high degree of personal integrity
Additional Salary Information: Salary determined by applicants experience and skillset
Chicago Research Center, Inc. is a privately owned and operated dedicated clinical research site, specializing in phase I-IV clinical trials for pharmaceutical and biotechnology industries. Since 2005, our team of experts have been involved in more than 1200 clinical research trials combined. This includes a broad array of specialties: including psychiatric, general medicine and sleep.