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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Summary

Patient-focused clinical operations team member talented at managing dynamic and cross-functional teams in a fast-paced, competitive environment. Results-oriented and proactive in resolving issues with exceptional organizational and communication skills.

Highlights
  • Exceptional time management skills
  • Collaborative
  • Procedure development
  • Employee engagement
Work Experience
Clinical Study Manager, 02/2014 to Current
Smith & NephewUs - Harrisburg, PA,
  • Managed study activities for multi-site, Phase II and Phase III clinical trials in the treatment of oncology (metastatic melanoma, renal cell carcinoma and epithelial ovarian, fallopian tube or primary peritoneal cancer).
  • Problem-solved regional study issues and risks with exceptional commitment to quality, communication and persuasion skills.
  • Managed the monitoring and data management activities of regional clinical research associates to include weekly dissemination of project related activities and study timelines, review of monitoring reports and task performance reports.
  • Coordinated and led the United States monitoring team to deliver quality, clean data within tight timelines in an effort to meet safety and PMR data cut-offs. Achieved 100% on-time completion rate for all query resolution data cut-offs.
  • Evaluated, approved and tracked site and vendor invoices based on applicable contracts and within study budget.
  • Analyzed and approved site-specific informed consents for Institutional Review Board (IRB).
  • Maintained the Country Trial Master File per corporate standard operating procedures (SOPs) and guidance.
  • Interacted with central IRBs and other external vendors.
  • Provided assistance to Regulatory Affairs as necessary for filing and other required compliance requirements.
  • Ensured all assigned trials were conducted in accordance with company SOPs and ICH/GCP guidelines.
Lead Clinical Study Associate (CSA), 2013 to 02/2014
Astellas Pharma Us, Inc.Pittsburgh, PA,
  • Integrated creativity and past experience to develop and improve CSA processes and procedures to enhance study delivery.
  • Developed and delivered training material and processes for CSA tasks and GSK systems.
  • Built relationships with multiple internal and external partners to understand their perspectives to enable and drive changes to overcome study obstacles.
  • Challenged CSA support and study teams to be flexible in seeking and making informed decisions while always putting customer and patients first.
  • Participated in the interviewing, hiring and training of new CSAs.
FT Legal Secretary 2000-03/PT Remote Billing Coordinator 2003-2014, 08/2000 to 02/2014
Pizonka, Reilley, Bello & McGrory, PCCity, STATE,
  • Oversee billing and ensure invoicing is completed accurately and on time
  • Prepare reports of billing activity for management
  • Assist with development and implementation of a billing database
Global Clinical Study Associate (CSA), 11/2010 to 2013
GlaxoSmithKlineCity, STATE,
  • Global CSA responsible for assisting Operational Science Lead (OSL) and various regional study managers across the globe and over multiple studies.
  • Assisted study team in their mission to successfully submit regulatory applications in the EU and US. Provided support to the Medical Writing group by managing the compilation of MOD Apps 2.7.5 and 5.4 Reference documents and collection of required references to ensure submission was completed within designated timeframe. Liaised between clinical team and TCS to ensure the references were received, copyright clearance attained and available in IMMS prior to submission. Completed listing of clinical references in an effort to support Australia in their pre-submission application.
  • Supported study team and quality group in preparation for FDA audit. Proactively worked with data management leaders and led effort to ensure accuracy of users within GSK systems. Interpreted the requests of the quality group and took on the responsibility to create required spreadsheets in which to compile all pertinent information for audit. Evaluated issues regarding FIDs collection. Supported audit of centre in France by compiling and providing requested documentation/information to LOC. Supported multiple groups prior to and during the actual FDA audit to include monitoring, clinical, safety and clinical supplies groups.
  • Provided reliable, transparent documentation from clinical studies in a timely manner to promote successful review and assessment by CEC at ASCO. Routinely took the lead role in deciphering which samples were related to subject events; Managed the tracking of study biopsy samples/pathology reports related to cutaneous events of primary interest for review at CEC meeting. Contributed in identifying issues and proposed ideas on how process could be improved for future studies. Coordinated and led telephone discussions between GSK and vendor to review events verses samples received. Created power point presentation slides to be presented at CEC meeting.
  • SCD Release 2 deployment initiative: Responsible for UAT testing and rolling out training for two of the seven integrated systems central to the SCD Release (eTrack 2.0 & Portal/eDX) by end of 2012
  • Managed communications with vendors in regard to shipping of study related investigator product and supplies.
  • Liaised with UPs contacts to develop a shipment process for ECGs. Created tracking spreadsheets and developed slide content for study processes. Presented at US, EU and INT monitor training sessions.
  • Created and compiled required reports for weekly study conduct meetings to communicate global study recruitment numbers.
  • Assured site selection/recruitment process conducted per study timelines; Assisted OSL in managing the registration and randomization to ensure recruitment goals were on target by tracking subject mutations, cohorts, PK samples, etc. Communicated daily with global, regional, internal and external study staff.
  • Assisted the operation science leader in developing and organizing the Study Procedure Manual (SPM).
  • Reconciled internal and external system interaction issues to include eTrack, InForm and RAMOS; Escalated complex requests to IT helpdesk or vendor contacts as needed.
  • Reviewed status of centres in GSK ClinicalTrials.gov with the status of centres in eTrack to guarantee accurate dissemination of information to public. Communicated issues identified and followed-up for resolution.
  • Supported DM in resolving identified queries in an effort to achieve data analysis timelines, etc.
  • Disseminated study updates in a timely manner to monitoring and/or study conduct team as appropriate.
Clinical Study Associate, 05/2008 to 11/2010
GlaxoSmithKlineCity, STATE,
  • Developed and maintained method of tracking for study budget spend. Reviewed and reconciled invoices/spend, and facilitated investigator payments.
  • Assisted in preparing Clinical Study Agreements (CSAs) for clinical sites.
  • Assisted in preparation and routing of study agreements and ensured fully executed agreements were in place prior to drug shipment and payment.
  • Ordered, distributed, managed and tracked study conduct tools and non-drug clinical supplies.
  • Created and maintained sponsor study records according to FDA/ICH Guidelines and internal SOP’s.
  • Traveled to clinical research organizations to conduct file review, reconciliation and other closeout activities as appropriate.
  • Communicated with regulatory and CTS to coordinate the shipment of clinical supplies.
  • Collected, reviewed and submitted required documentation to regulatory operations throughout study.
  • Liaised with meeting planning vendor in the logistical planning of study meetings (Investigator, CRO, and Coordinator). Assembled materials and attended to support meetings.
  • Reconciled FIDS, CARDS and sponsor study records to provide documentation in support of modular appendices for Clinical Study Reports.
  • Assisted with the review of informed consents and highlight changes for Study Manager.
  • Participated in site selection process.
  • Provide operational support for delivery of assigned studies or programs on time.
  • Adhered to the Clinical model, collaborating with internal key matrix partners and external customers.
  • Provided support, expertise and acted as central point of contact for the eTrack application for Business Area; Communicated eTrack relevant information to the supported area in a timely manner when requested.
Clinical Project Coordinator/Financial Analyst @ GSK, 08/2006 to 03/2008
Manpower ProfessionalsCity, STATE,
  • Assisted study manager and provided project management task support as part of the study management team.
  • Reviewed and approved month end close activities to include accruals and reconciliations
  • Reviewing clinical research organizations monthly current estimates (CEs) forecasts and preparing variance spreadsheets for finance department
  • Developed and maintained study budget comparison/reconciliation spreadsheets
  • Reviewed and approved invoices from CROs; Maintained GSK invoice summary spreadsheets and followed up with accounts payable regarding invoicing issues
  • Interact with CRO to resolve invoicing, forecasting and other budget discrepancies
  • Provided support, expertise and acted as central point of contact for the eTrack application for Business Area and CRO; Communicate eTrack relevant information to the supported area in a timely manner when requested
Clinical Quality Associate, 2003 to 07/2006
Quality Data Services, Inc.City, STATE,
  • Forecasted and processed Investigator Grant Payments and Investigator Review Board (IRB) payments
  • Maintained grant payment tracking spreadsheets and ensured compliance with study-specific contractual agreements
  • Managed clinical studies’ reimbursable expenses: client bill-backs and invoicing
  • Generated and reviewed Clinical Study Agreements (contracts) between study sponsor and site
  • Supervised and coordinated administrative activities of Regional Clinical Research Associates (CRA)
  • Ensured accuracy of Regional CRA’s monitoring activities network database and generated detailed reports to sponsors
  • Approved timesheets and expenses for Regional CRA’s; Insured compliance with study budget
  • Drafted CRA contracts and provided payments to CRA’s for clinical study travel expenses
  • Trained new hire monitors on timesheet and expense software, relevant SOP’s and related documents
  • Developed study materials: Case Report Form’s (CRF), CRF Guidelines and SOP’s
  • Conduct operational start-up activities to support assigned clinical project teams
  • Review and track regulatory documentation Review regulatory documentation in preparation of audit
  • Knowledge of applicable government regulations, including those relating to Good Clinical Practices
  • Created and maintained study-required Tracking Systems: regulatory, patient, protocol deviation, etc.
  • Interacted with sponsor, investigators and site personnel
  • Assisted with Project Management tasks including teleconferences, meeting minutes and status reports
Accomplishments
  • Recipient of the Silver Award in 2014 for support provided during FDA inspection.
  • Recipient of the Bronze Award in 2013 for support in creation and delivery of the Flexible Resourcing Model training program.
  • Recipient of the Bronze Award in 2013 for providing technical guidance and patient advice on complex local trial.
  • Recipient of the Silver Award in 2012 for supporting the delivery of documentation requested by the FDA for their pre-NDA OSI pilot program.
  • Recipient of the Gold Award in 2011 in recognition of demonstrating corporate valued behaviors in being solution driven and using results-oriented critical thinking skills.
  • Recipient of the Bronze Award in 2010 for support in cascading of critical study information both regionally as well as globally.
  • Recipient of the Silver Award in 2009 for efforts in conducting and facilitating training of the eTrack Foundation Course to regional oncology unit to meet critical business need.
Education
Associate of Science: Business Management, Expected in 1983
York College of Pennsylvania - York, PA
GPA:
Skills
  • Technical Skills: Word, Excel, Outlook, Access, PowerPoint

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Resume Overview

School Attended

  • York College of Pennsylvania

Job Titles Held:

  • Clinical Study Manager
  • Lead Clinical Study Associate (CSA)
  • FT Legal Secretary 2000-03/PT Remote Billing Coordinator 2003-2014
  • Global Clinical Study Associate (CSA)
  • Clinical Study Associate
  • Clinical Project Coordinator/Financial Analyst @ GSK
  • Clinical Quality Associate

Degrees

  • Associate of Science

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