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.
• 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

• 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

• 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

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

• 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