Cory Pace Email & Phone Number

Tomball, TX, US

Waltham, MA, US

Wilmington, NC, US

New Jersey, NJ, US

Houston, Texas, US

• Collecting and tracking a multitude of information for patients who are registered on approved protocols.
• Abstracted data from EMR into sponsor preferred databases (InForm and Medidata Rave)
• Ran reports, issued and resolved queries via the database platform
• Developing study specific case report forms (CRFs) and other protocol specific documents
• Collected and evaluated the data for critical study events, which must be reviewed with the Principal Investigator.
• Reviewed of the data for critical study events which includes evaluation of adverse events (AEs) and Serious Adverse Events (SAEs) using the NCI Common Toxicity Criteria 4 (CTC-4). This individual is accountable for.

Houston, Texas, US

Princeton, New Jersey, US

• Responsible for data integrity and the transcribing of research patient data and study-related information into case report forms.
• Abstracted data from the electronic health record (EHR) into both Inform and Medidata Rave as required by sponsor. Use both EDCs to perform query resolution.
• Completed data reporting in accordance with good clinical practice (GCP), federal regulations and institutional policies.
• Communicated verbally and in writing as needed or as requested by the principal investigator of the study.
• Created protocol-specific documents.
• Maintained local logs/progress reports and local/third party databases to track study participants.

• Assisted in Essential Document Collection, Review, and Maintenance, including resolution of investigative site/data queries.
• Tracked clinical trial management information
• Documented site and client contact and study interactions
• Identified, monitored, and tracked out-of-scope activities
• Liaised with project team members regarding study site issues
• Set up and maintained Trial Master File

Durham, North Carolina, US

• Assisted in the processing of incoming and outgoing Lifecycle Safety data and reports, including mailings and distribution of LifeCycle Safety data to Investigators marketing authorization holders, customers and.
• Collected and tracked incoming Adverse Event (AE) and endpoint reports in addition to tracking and archiving case folders and project files.
• Prepared documents and files for meetings and committees (i.e. endpoint duplication/dossier compilation); and any other project related meetings.
• Coordinated and checked incoming documents from sites against checklist to ensure documents met requirements.
• Copied documents, stuffed envelopes, and distributed data using courier services and tracking and filing submitted materials.
• Assisted with project start-up tasks; collecting, review and tracking of essential regulatory documents

Durham, North Carolina, US

• Updated data in InForm and Medidata Rave based on query responses and or DCFs
• Generated, tracked and integrated queries based on validation specifications
• Prepared study documents to be file in Trial Master File
• Maintained electronic folders and documentation
• Presented project status reports and other information to internal team
• Performed tasks associated with database QC and CRF to database audits

• Processed, enrolled and tracked CRFs per work instruction
• Updated data based on data clarification response
• Created manual queries for data discrepancies identified on Missing Page Reports, & Clinical Listings
• Performed SAE Reconciliation
• Participated in User Acceptance Testing; created test patient data for database screen testing, maintaining test issues log and other documentation associated with UAT
• Developed QC/Audit Specifications