Senior Clinical Data Manager

• Jun 2023 - Present

Clinical Data Manager II

• Oct 2021 - Jul 2023

Clinical Data Manager I

• May 2020 - Oct 2021

Clinical Trial Launch Specialist

• Mar 2019 - May 2020

• Create, initiate and maintain participant-directed materials and source document templates per study-specific requirements. • Review and revise sponsor consent form templates, if needed, for clarity and accuracy, and according to research ethics board guidelines. • Collaborate and communicate with various internal departments and sponsor personnel to submit the initial application for ethics approval and institutional authorization • Navigate responses to research ethics board… Show more • Create, initiate and maintain participant-directed materials and source document templates per study-specific requirements. • Review and revise sponsor consent form templates, if needed, for clarity and accuracy, and according to research ethics board guidelines. • Collaborate and communicate with various internal departments and sponsor personnel to submit the initial application for ethics approval and institutional authorization • Navigate responses to research ethics board queries after review and liaise with internal and external vendors • Provide support to other team members in completing initial and amendment applications

Clinical Data & Regulatory Coordinator

• Mar 2018 - Mar 2019

• Coordination of oncology trials with a focus in malignant hematology, from study activation through to trial closure. • Trained in ICH-GCP, FDA, and US federal code and Tri-Council regulations and has experience with interpreting the applicable regulations in order to ensure compliance as well as obtaining high-quality data. • Monitoring and entry of clinical trial data into electronic data capture (EDC) systems and timely query resolution in accordance with the trial protocol… Show more • Coordination of oncology trials with a focus in malignant hematology, from study activation through to trial closure. • Trained in ICH-GCP, FDA, and US federal code and Tri-Council regulations and has experience with interpreting the applicable regulations in order to ensure compliance as well as obtaining high-quality data. • Monitoring and entry of clinical trial data into electronic data capture (EDC) systems and timely query resolution in accordance with the trial protocol, hospital, and departmental guidelines and professional SOPs. • Review and provide feedback in the database design process and participated in EDC User Acceptance Testing (UAT) of the Medidata RAVE EDC system. Trained in and have experience working with InForm, RAVE, imedidata, Bioclinica, and OpenClinica EDC systems. • Ensure protocol requirements are implemented accurately by all study staff and that study participants are following protocol requirements. Document protocol deviations, liaise with internal and external vendors to propose and implement Corrective and Preventive Actions (CAPAs) and follow up on resolutions. • Attend regular disease site meetings and provide updates on trial status and data management timelines (including database lock deadlines). Participate in regular team meetings, and attend investigator’s meetings. • Maintain the trial master file and study binders in accordance with the regulatory guidelines. • Prepare for and provide support to quality control audits/regulatory inspections and sponsor monitoring visits. Primary contact person for data management and regulatory activities.

Clinical Research Assistant

• Oct 2015 - Jan 2018

• Prepared regulatory documentation for timely REB submission including initial reviews, study amendments, annual continuing reviews, and reportable events/notifications (has experience working with OCREB/CTO and NYGH REB) • Screened potential study participants for eligibility according to the trial protocol’s inclusion and exclusion criteria and obtained proper written informed consent from each study participant prior to participation in the study • Represented the clinical research… Show more • Prepared regulatory documentation for timely REB submission including initial reviews, study amendments, annual continuing reviews, and reportable events/notifications (has experience working with OCREB/CTO and NYGH REB) • Screened potential study participants for eligibility according to the trial protocol’s inclusion and exclusion criteria and obtained proper written informed consent from each study participant prior to participation in the study • Represented the clinical research department by maintaining collaborative relationships with study staff, clinical team, other hospital departments, and sponsor personnel Show less • Prepared regulatory documentation for timely REB submission including initial reviews, study amendments, annual continuing reviews, and reportable events/notifications (has experience working with OCREB/CTO and NYGH REB) • Screened potential study participants for eligibility according to the trial protocol’s inclusion and exclusion criteria and obtained proper written informed consent from each study participant prior to participation in the study • Represented the clinical research… Show more • Prepared regulatory documentation for timely REB submission including initial reviews, study amendments, annual continuing reviews, and reportable events/notifications (has experience working with OCREB/CTO and NYGH REB) • Screened potential study participants for eligibility according to the trial protocol’s inclusion and exclusion criteria and obtained proper written informed consent from each study participant prior to participation in the study • Represented the clinical research department by maintaining collaborative relationships with study staff, clinical team, other hospital departments, and sponsor personnel Show less

Optometric Assistant

• Sep 2014 - Aug 2015

• Conducted preliminary testing on patients utilizing standardized machines • Assisted and advised patients on lens and frame selection • Repaired and adjusted eyewear (both metal and plastic) according to patient needs and preferences • Conducted training for new contact lens wearers • Daily reception duties including appointment scheduling, responding to emails, and resolving walk-in queries with consistent high-quality customer service • Conducted preliminary testing on patients utilizing standardized machines • Assisted and advised patients on lens and frame selection • Repaired and adjusted eyewear (both metal and plastic) according to patient needs and preferences • Conducted training for new contact lens wearers • Daily reception duties including appointment scheduling, responding to emails, and resolving walk-in queries with consistent high-quality customer service