Chicago, Illinois, United States
A detail-oriented and diligent Clinical Research Professional with over 5 years of Coordinator experience and excellent communication skills. Passionate about patient care and safety in relation to proper conduct of clinical trials and study protocol adherence. Comfortable in all roles, from working independently or as a leader, to being an active, reliable team member.
• Functioning as primary and back-up study coordinator for a variety of Phase II-IV trials with duties ranging from study start up, recruitment, screening and obtaining informed consents, study visits, maintenance of source documents and regulatory binders, laboratory processing, investigational product accountability, monitoring activity, and study closeouts, supporting multiple Principal Investigators • Maintaining studies in compliance with HIPAA, GCP, and ICH guidelines, all applicable federal, state, and local regulations, study protocols, and site-specific SOPs using both traditional paper documentation and electronic CTMS • Performing regulatory duties, including annual continuing reviews, IRB approvals, submissions, and reporting (safety and deviations) • Conducted annual internal auditing and quality assessments for ongoing trials at site, including preparation for an external, 3rd-party audit • Collaborating and communicating regularly with all members of study team from sponsors, CROs, and additional ancillary vendors in order to ensure the smooth and proper conduct of studies
• Principal study coordinator for two long-term registry studies with over 300 active subjects – conducted patient interviews and detailed medical chart reviews, took vitals, collected and reported safety data into an electronic data capture system • Communicated regularly with CROs and sponsors, and prepared studies for interim monitoring visits • Served as backup coordinator on various Phase II, III, and IV studies through site initiation processes, subject recruitment, obtaining informed consent, study visits, laboratory processing, and closeouts • Conducted a comprehensive revision and internal audit of 8-year-long registry study to ensure accurate historical data reporting, which included adding large quantities of missed data and resolving official sponsor-issued queries • Took initiative to revise site-specific forms and documents in order to streamline and clarify processes and procedures – included creating source documents for all incoming studies
• Prepared and distributed materials for various laboratory courses in the Biology department; duties included aliquoting/diluting chemical solutions, prepping microorganism cultures, handling plant and animal specimens, and mixing and pouring agar plates • Mastered aseptic technique, utilized water baths, biosafety cabinets, and fume hoods, maintained lab bench equipment, operated autoclaves, and assisted in biohazardous waste disposal • Headed an end-of-semester project that audited, reorganized, and restocked the main storage facilities in accordance to the upcoming semester's syllabi, and to optimize the space available