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Yolanda Latta_Septemeber 2015
- 1. Yolanda B. Latta 208 Norwood Ct South, Mebane, NC 27302 • 919-819-3276 • ylatta2002@yahoo.com SUMMARY Quality-focused clinical operations support professional with at least 15 years of experience in the pharmaceutical industry across several therapeutic areas. Technically proficient in eTrack, FIDS Database, Randomization and Medication Ordering System (RAMOS) – Proprietary, Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), SharePoint (Team Site), Outlook, Interactive Voice Response System (IVRS), Medical Terminology, and GCP-ICH guidelines. ▪ Proactive problem-solver ▪ Efficiently manage timelines of multiple priorities ▪ Effective interpersonal skills ▪ Highly Organized EXPERIENCE February 2015 - Present PAREXEL, INC. (GlaxoSmithKline business unit transferred to PAREXEL), Research Triangle Park, NC Clinical Monitoring Associate, II (in-house) ▪ Manage sites and protocols across multiple therapeutic areas ▪ Ensure receipt and quality of required regulatory documents, ▪ Track and obtain regulatory approval for drug shipments ▪ Provide operational support for delivery of assigned studies according to study timelines ▪ Communication with Clinical Operations, CRAs, Project Management, and Vendors ▪ Enter and maintain information in different database systems (eTrack, FIDS Database, Randomization and Medication Ordering System) April 2005 – February 2015 GlaxoSmithKline, Research Triangle Park, NC Clinical Study Associate (Title Changed) (June 2007 –February 2015) ▪ Ensured receipt and quality of required regulatory, financial, and legal documents, tracked and submitted to appropriate departments; and obtained regulatory approval for drug shipments ▪ Provided operational support for delivery of assigned studies or programs on time and within budget ▪ Collaborated with Clinical Study Associates (CSAs) to ensure quality and timely completion of deliverables ▪ Contributed to Leadership Team for resourcing as a consultant ▪ Handled document destruction requests
- 2. ▪ Coordinated and compiled information for study reports ▪ Provided CSAs, study teams, monitors support to implement End to End Model from study start through report completion ▪ Resolved, coded, approved, and submitted invoices to Accounts Payable ▪ Entered and maintained information in systems (eTrack, FIDS Database, Randomization and Medication Ordering System) Clinical Support Specialist (April 2005 – June 2007) ▪ Set up, obtained, and maintained sponsor study records according to GCP/GSK processes ▪ Entered and maintained information in Clinical Trial Management System (CTMS) ▪ Coordinated and compiled information for clinical study reports ▪ Assisted Study Manager with Serious Adverse Events (SAEs); gathered and disseminated SAEs to appropriate personnel ▪ Resolved routine requests and escalated complex requests ▪ Assisted in preparing Clinical Study Agreements for clinical sites ▪ Received, coded and submitted invoices to Accounts Payable ▪ Completed administrative duties as required June 2000 – April 2005 Clinical Trial Services, Durham, NC Onsite Monitor (September 2003 – April 2005) ▪ Conducted onsite interim monitoring visits to ensure integrity of clinical data ▪ Ensured proper storage, dispensation, and accountability of clinical trial supplies ▪ Prepared reports outlining findings at site visits ▪ Initiated site personnel, including the site pharmacist on completing study documents and reviewed study procedures ▪ Actively monitored 13 sites Senior Project Coordinator (June 2002 – April 2005) ▪ Interacted with Management, Quality Control, Production, and Distribution. ▪ Designed labels to meet specific country language and regulatory requirements. ▪ Presented in-services provided for assembly and shipping. ▪ Designed drug accountability documents. ▪ Initiated team meetings and conference calls. ▪ Attended Investigator Meetings. ▪ Consulted with the Information Technology (IT) Department for trial start up. ▪ Worked with the Interactive Voice Response System (IVRS) vendor to resolve kit inventory issues. ▪ Coordinated monthly meetings with fellow Project Coordinators. ▪ Trained new personnel on Standard Operating Procedures (SOPs). ▪ Provided administrative support to clinical trial projects as needed (i.e., taking minutes, tracking, filing, and scheduling). Project Coordinator (July 2000 – June 2002) ▪ Interacted with Management, Quality Control, Production, and Distribution. ▪ Participated in conference calls and team meeting. ▪ Communicated with study site coordinators on drug supply.
- 3. ▪ Generated monthly reports and follow-up on incomplete, inaccurate, or missing drug accountability documents. ▪ Created Distribution and Assembly Instructions. ▪ Coordinated ordering and shipping of study medication supplies with company vendors. Quality Assurance Inspector (June 2000 – July 2000) ▪ Monitored production area for cleanliness and adherence to current Good Manufacturing Practice (cGMP). ▪ Ensured adherence to SOPs by all personnel. ▪ Reviewed batch paperwork for accuracy and completeness. ▪ Assisted in internal and external audits as required. ▪ Initiated and coordinated Quality Incident Reports and Deviations as required. October 1998 – June 2000 Duke Clinical Research Institute – Pharmacy Durham, NC Clinical Supply Specialist II, Quality Control (July 1999 – June 2000) • Verified and approve the receipt of clinical supply labels. • Coordinated & scheduled packaging and shipping dates with Production Manager. • Verify the labeling process prior to submitting to Production Staff. • Performed final checks of the Clinical Trial packaging process. • Performed checks in the Receiving and Shipping Department. Clinical Supply Specialist I, Production (October 1998 – July 1999) • Record activities and packaging steps on assembly documents according to SOPs. • Label study medication and assemble into study specific drug kits. • Prepared assembly for packaging operations. • Received study medication and packaging supplies from the warehouse for assembly job. September 1996 – October 1998 Duke Medical Center, Durham, NC Pharmacy Technician • Communicated with the Medical staff & patients to ensure accurate dispensing of medication. • Performed data entry of patient’s profile and patient’s drug charges account. • Dispensed unit dose of drugs. • Mixed intravenous drugs. • Answered phone calls from medical staff, stocked and maintained inventory.
- 4. September 1993 – September 1996 UNC Hospital, Chapel Hill, NC Pharmacy Technician • Interacted with Medical Staff and Patients • Dispensed drugs in an outpatient setting • Data entry of patient’s drug profile and prescription labels • Mixed Intravenous Chemotherapy drugs • Answered phone calls from patients and medical staff, stocked, and placed inventory via electronic device EDUCATION Mount Olive College, Research Triangle Park, NC Associate Degree in Science Durham Technical Community College, Durham, NC Certificate Program, Clinical Trials Research Associate Durham Technical Community College, Durham, NC Certification, Pharmacy Technology