Cenk Pusatcioglu, Phd Email & Phone Number

Chicago, Il, Us

North Chicago, Illinois, United States

• Lead the cross-functional study team on clinical studies to manage critical path and milestones.• Create the study budget and provide oversight of spend against approved budget.• Supervise study management associates on clinical operations and career development in an inclusive and innovative environment.

North Chicago, Illinois, United States

• Provide oversight of cross-functional teams and vendors for phase 3 trials in the Neuroscience therapeutic area.• Responsible for providing study updates to key stakeholders and ensuring that database lock activities are completed per plan. • Participate in business initiatives aimed at improving clinical data review platforms and processes. • Fluent with clinical systems including EDC, IRT, CTMS and eTMF.

North Chicago, Illinois, United States

• Assigned to a phase 3 trial in the General Medicine Therapeutic Area that covers over 100 sites in the United States, Canada and Puerto Rico.• Collaborated with cross-functional teams including site monitors, data management, safety and statistics for timely data cleanup, query resolution and database lock.• Developed training material for study site staff and site monitors. • Presented at investigator meetings and site monitor teleconferences.

North Chicago, Illinois, United States

• Assigned to the Midwest, Southwest and Pacific Northwest United States regions (40 sites) to ensure timely recruitment, query resolution and triaging of study issues.• Collaborated with site monitors and the medical director to establish that assigned enrollment procedures are completed per plan.• Managed the central imaging and lab vendors with weekly meetings, site training/qualification, review of queries and providing feedback for process improvements. • Generated reports with EDC and IRT to review study metrics and proactively resolve issues.

Deerfield, Illinois, United States

• Coordinated efforts associated with the compilation of site level regulatory document submissions for phase 1-3 clinical trials.• Prepared, reviewed and managed ethics committee submissions for domestic or international projects, including protocol, informed consent template, financial disclosure, privacy protection and site staff qualification.• Communicated with central and local/academic institutional review boards (IRBs) and independent ethics committees (IECs) regarding pre-submission strategies or clarification and follow-up of submissions under review.• Established, maintained and reviewed the trial master file (TMF) to ensure audit readiness.

Chicago, Illinois, United States

• Managed day-to-day operations and clinical staff training for trial implementation. • Facilitated local institutional review board (IRB) paperwork and start-up operations in coordination with study sponsors and monitors.• Negotiated contracts with study sponsors to assure successful implementation.• Led the development of clinical trial protocols, informed consent forms, and privacy protections for study submissions.

Chicago, Illinois, United States

• Managed clinical operations alongside physician and nursing staff in ambulatory surgical centers (ASC) and endoscopy clinics. • Obtained research participant consent; performed phlebotomy; assessed anthropometrics, and administered medical history questionnaires within clinics.• Assessed and analyzed dietary intake of research participants using the Block Brief Food Frequency Questionnaire.

Chicago, Illinois, United States

• Captured and managed dietary intake data of research participants with Nutrition Data System for Research (NDSR) software.• Administered and analyzed Dual-energy X-ray absorptiometry (DXA) scans on research participants.

Bachelor Of Science (B.S.), Food Science And Human Nutrition

Doctor Of Philosophy (Phd), Nutritional Sciences