Lucy N. Email & Phone Number

Chicago, Illinois, United States

- Provides support to Project Team and Clinical Operations Team. - Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects. - Serves as primary contact for assigned research sites. - Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period. - Responsible for the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan. - Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines. - Verifies the rights and well-being of trial subjects are protected. -Reconciles site regulatory binder assuring collection and completeness of regulatory documents.

Chicago, Illinois, United States

- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality. - Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity. - Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion. - Observed clinical studies and assessed health outcomes in groups of participants to support research plan. - Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues. - Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans. - Maintained site monitoring schedules to facilitate effective communication with members of clinical team.

Chicago, Illinois, United States

- Conducted patient data monitoring for accuracy and protocol compliance. - Conducted site qualification, initiation and site closeout visits and completed all appropriate documentation related to the visits. - Provided support in site recruitment as well as support in the compiling and analysis of patient data. - Obtained/reviewed/processed regulatory and administrative documents from investigative sites. - Reviewed documentation of blood samples/specimens and tomorrow slides submitted by sites.

Chicago, Illinois, United States

- Performed all data management tasks as appropriate to include, but not to be limited to: data review and query management to ensure that quality standards (both internal and client) were achieved. - Performed reconciliation of the clinical database against safety data, laboratory data and other third-party data. - Reviewed clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raised queries to resolve erroneous, missing, incomplete or implausible data. - Generated, resolved, and tracked queries to address problematic data identified during data review activities and apply proper modification/correction to the database. - Ran ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trials.