Jacqueline M. Email & Phone Number

United States

•Assist with study site activation activities to ensure timely site activation •Register investigator sites in Pfizer registries as required•Support and/or coordinate central Investigator Review Board (IRB) submissions when needed•Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, regulatory packages, confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status•Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner•Prepare, validate and submit regulatory documents, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines•Problem solving identified issues with appropriate timely escalation to the monitor (Site Relationship Partner)•In collaboration with the Site Relationship Partner, conduct or oversee investigator site activation activities, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation•Assist monitors (Site Relationship Partner) with preparation for site visits (running reports, QC of files, resolving items from previous visits)•Monitoring site performance and creating action plans for sites not meeting expectations in conjunction with the on-site monitor•Submitting within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status•Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed•Work with investigator sites throughout the study to complete required ongoing study documents such as documents for protocol amendments and FDA 1572 revisions•Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow

• Supporting the Lead SSU specialists by providing updates during weekly internal team meetings• Sending regulatory packets to selected sites and following up with those sites about their progress• Collecting and reviewing essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.• Aiding sites with answering any questions that are required for their local IRB/ethics committee submissions• Reviewing, modifying, and customizing site specific Informed Consent Forms (ICF)sand following up with sponsors and sites about the ICFs• Coordinating translation of Informed Consent Forms as needed• Serving as IQIA Biotech liaison with central IRB submissions• Maintaining up to date and accurate tracking on the start-up status for each site in applicable systems such as Infostart and IL2• Responsible for transitioning sites from Study Start Up to File Maintenance representative• Adhering to study timelines, documents including escalating study challenges as well as communicating study/site updates to the Project Manager and SSU Lead/Manager• Assisting other teams (Feasibility) with their required tasks as needed

• Received start-up packet from sponsor• Initiated and monitored study start-up activities• Completed HIPAA waiver, consent form, research summary, CPC study form, complete pathology form, 1572, FDFs• Obtained CVs, MLs, and CITI-GCP, and other study specific training from investigators, sub-investigators, and study team• Collaborated with appropriate committees for successful IRB approval• Completed study start up tracking within OnCore, the Clinical Research Management System and eReg, the electronic Regulatory Affairs binder for documentation• Obtained required signatures on all regulatory documents• Prepared study-specific documentation for auditor or study monitor review• Communicated diligently with sponsors of clinical trials and study team key personnel• Maintained a tracking tool to monitor progress of multiple tasks/studies• Submitted protocol amendments as well as updated the ICF and other regulatory documents associated with the amendment• Scheduled and executed monitoring visits• Scheduled, organized, and executed close out visits• Alliance team: Aided team in managing clinical trials from 8 oncology disease groups within the National Clinical Trials Network for Cooperative Group studies. • Alliance team: Worked closely with study coordinators to prepare and submit adverse event reports• Alliance team: Processed amendments from the CTSU website

Greensboro, North Carolina, United States

sted clinical research coordinators with patient visits, documentation and CRF completion• Maintained and updating regulatory documents for various trials• Assisted with subject data entry using electronic medical records and sponsor provided EDC systems• Maintained effective communication with research staff, sponsors, and IRB’s• Assisted in preparing subjects workflow and scheduling• Assisted in scheduling monthly meetings and recording minutes• Collected basic vital signs and perform EKGs per trial protocol• Performed chart reviews prior to clinical research monitor review• Maintained current license and CV’s from all research staff• Organized work area and maintain proper equipment storage• Implemented quality control processes throughout the conduct of the trial. • Participated in clinical floor activities with research staff to ensure adequate clinical support for trial activities• Monitored the progress of research activities; develops and maintains records of research activities• Planned, implemented, and maintained data collection and analysis systems in support of research protocol• Coordinated the collection and analysis of research data

• Created and implemented a community health fair for migrant farmworkers • Created promotional items for the health fair• Networked and partnered with community organizations and health professionals • Educated migrant farmworkers on the importance of proper nutrition, pesticides, and STDs

• Responsibilities included setting up blood, bone marrow, or lymph node specimens into the appropriate cultures and awaiting the growth of the white cells in order to harvest the cells • Responsible for the preparation of reagents required to set up and harvest the appropriate cells• Dropped harvested cells onto slides within the Thermotron for further analysis.• Stained dropped slides for karyotyping • Captured blood and bone marrow metaphase cells from banded slides and karyotyped chromosomes from the captured metaphase cells

Chapel Hill, North Carolina, United States

• Entered criteria air pollutants (particulate matter, ozone, sulfur oxides, nitrogen oxides, carbon monoxide, and lead) into a novel database system (Health and Environmental Research Online). • Researched organized scientific papers on criteria air pollutants• Produced tables and reports using Microsoft Excel and Word