Clinical Research Coordinator

2 weeks ago

Urbana IL, United States CARLE Full time
The hEDS GENE Study is looking for a data analyst to assist in its ongoing efforts to identify genes associated with the connective tissue disorder hypermobile EDS (hEDS). This group has recently moved to Carle Health/Carle Illinois College of Medicine/University of Illinois and is reconstituting a term to gather and analyze samples collected from people with hEDS. The primary duty of the Clinical Research Coordinator (CRC) will be to facilitate and coordinate the daily activities of the hEDS 'Omics study including scheduling and communicating with participants, obtaining informed consent, coordinating study procedures including physical examination and sample collection, and overseeing sample analysis and organizing returned data. The CRC will work with the PI to develop new protocols, including a registry of patients identified clinically. These duties entail budget development, IRB submission, maintenance of regulatory documents, and development material transfer agreements for samples. The CRC will enter study data into and retrieve study data from research databases. Basic statistical analysis may also be required. Duties will require close coordination with collaborators at various institutions including the University of Illinois, University of Arizona, and University of North Carolina.
  • Works in collaboration with the Principle Investigator (PI).
  • Assists Regulatory Specialist in maintaining regulatory documents.
  • Conducts protocol and feasibility evaluation.
  • Assesses patient population, recruitment and enrollment strategies.
  • Recruits and manages trial subjects to include screening patients for protocol eligibility, covering informed consent, screening and inclusion/exclusion of the subjects adhering to safety and compliance issues.
  • Performs and/or coordinates tissue processing and subject's participation in clinical diagnostic procedures.
  • Assists with maintenance of research related inventories for approved studies.
  • Assists in accurate and timely data collection, collection of source documents documentation, data entry, and reporting.
  • Schedules, coordinates planning and participates in monitoring and auditing activities. Participates in required training and education programs.
  • Assists PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to but not limited to, protocol requirements, schedule of subject visits, execution of research plan.
  • Retains all study records in accordance with sponsor requirements. Maintains effective and timely communications with sponsor, research subjects and PI during the course of the study. Maintains documentation of training.
  • Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards.
  • Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Reports instances of noncompliance to appropriate institutional oversight body.
  • Recognize potential obstacles and work to resolve them within set timelines.
  • Close-out of the clinical trial, contributing to research article, audit preparation, trial closure, communication with authorities and other disciplines involved, assisting in the final study report, completing financial obligations and archives study materials.
  • Statistical analysis of study data

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