Jill Quigley Email & Phone Number

Raleigh-Durham, North Carolina Area

Processed and coordinated all tasks involved for Clinical Events Classification for two different Clinical Trial Programs (6 different protocols)Handled all tasks for event processing for cardiovascular outcomes and gastroenterology (Pancreatitis events) including processing new triggers and queries, review source documents and compiling dossiers, in preparation for Physician review Identified additional potential endpoints Event reconciliation between clinical database and adjudication platformReviewed Physician disagreements from paired review and prepare events for full committee Prepared Patient Profiles: reduced safety medical monitor profiles to a clinical endpoint adjudication relevant patient profilesAttended project specific internal team meetingsAttended Committee meetings Mentored other CTC personnelHandled all tasks for Clinical Trials Assistants when needed: processing email inbox for new source documentation, entering new triggers into internal tracking system, sending documentation for translation, redaction of new source documentation

Princeton, Nj

Review of source documents for Medical Writer approval in a fast paced, detail-oriented environment• Therapeutic areas include: Chronic Pain, Neurology and Joint Disorders (5 protocols)• Review of local and central imaging reports• Daily review of source documents and development of final dossier for Narrative/Medical Writers • Provide daily updates to management/sponsor, via Live Master Trackers• Daily interaction with clinical site personnel to achieve compilation of complete dossier• Process sponsor RADs (Request for Additional Documentation), prioritizing information needed and communicating with site to address the queries

Princeton, Nj, Usa

Experienced in working with multiple sites participating in Phase 3 clinical trials. Therapeutic areas include: Cardiology, Diabetes, Respiratory and GoutReceived extensive training from Covance in the following areas (but not limited to): GCP, SOPs, CAPAs, Quality Assurance and Quality Control, Communication with IRB/IEC, Informed Consent of Trials Subjects, Randomization procedures and unblinding, Adverse drug reaction reporting, Patient confidentiality. Training was done on a yearly basis, depending on the subject matter Exceeded client expectation daily. Contributed to improvements in endpoint processes that led to a 50% decrease in overall cycle timesWithin a month, resolved and closed out 85% of outstanding queries which resulted in receiving an "achieving excellence" award from the companyDirect experience receiving and processing events for adjudication as first reviewer. This included closely reviewing all documents received for each dossier, as well as working with the Drug Safety department to obtain all possible pertinent documentsCollected documents (all pertinent records available from the patient's hospital stay) and performed redactions required for adjudication review. Provided daily administrative support to Senior Director, Project Managers and LeadsManaged incoming and outgoing translations for adjudication reviewMentored new hires in the department

Princeton, Nj, Usa

Provided support to clinical team, assisting with filing, TMF, Investigator files, audits and archiving for US and global studies • Therapeutic areas include: Oncology and Cardiology• Exceeded client’s expectations on study timelines on multiple clinical trials, including assisting with COV’s, providing final QC on TMF and Investigator files• Attended Investigator Meeting in San Francisco, CA - Dec 2008• Updated lab shipments and eDiary spreadsheets daily• Performed Sr. CPA duties for four studies, all global• Confirmed sites receipt of drug shipments• Maintained Central and Investigator files for current global studies• Completion in a timely manner of meeting minutes for multiple studies, internal and external meetings• Prepared documents and other materials for archiving at close of study• Prepared Central and/or Investigator files for auditing at the close of study• Appropriate use of billable study hours• Mentored new CPAs, including but not limited to SOP reviews, processes and procedures, Trial Tracker, TMF and eTMF