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 ensuring that these events are expeditiously reported to the Principal Investigator as well as to all regulatory agencies. •Responsible for preparation of study specific reports •Assisted with audits/regulatory inspections and participates in study initiation meetings and study close out activities•Interacted with study sponsors to facilitate protocol activities and maintain current study documents

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.•Interacted with study sponsors to facilitate protocol activities and maintain current study documents.•Submitted serious adverse event (S/AE) reporting and follow up as needed•Tracked, managed, transcribed, and reported study participant drug diary data.•Maintained online RRO staff activity log.•Assisted research coordinators and nurses with clinical research scheduling and study operational activities.•Corresponded with study volunteers.•Assisted with study participant screening and recruiting.•Participated in RRO protocol feasibility assessment.•Actively participates in protocol meetings.•Traveled to out-of-state investigator and site initiation meetings.•Prepared for sponsor monitoring visits and responds to sponsor queries.•Assisted with audits/regulatory inspections and participates in study initiation meetings and study close out activities.•Participated in the IRB submittal process (Ex: Completing the require Human Subject Protection Training, determining which application to submit, obtaining the appropriate signatures/approvals, gathering and assembling all study-related documents and emailing the application. Following the necessary steps until IRB approval)•Performed quality assurance activities on essential documents to ensure that all protocol requirements had been met

•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•Supported Clinical Endpoint Coordinator with endpoint processing•Assigned Unique Event Identification Number (UEID)•Performed clinical endpoint package processing, query processing and non-event processing•Corresponded with clinical study sites and CRAs to resolve endpoint package discrepancies•Created and maintained endpoint patient files and maintained database tracking

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 regulatory authorities.•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•Performed patient follow-up; called sites to request source documents and resolved any outstanding queries

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 •Created work instructions, study related data entry guidelines, and updated S.O.Ps•Prepared patient profiles/dossiers for physician review and committee meetings including archival of patient event packets

•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•Participated in QC Audit (Critical Variable & Post-Close)•Coordinated and performed study specific training•Created study specific guidelines (Data Entry Guidelines, CRF Completion Guidelines)•Performed data entry of patient’s ophthalmology data into database.•Reviewed CRFs for data anomalies