Stefanie Chamis
Prosper,TX
Summary
Dynamic professional with a successful background in leadership and optimizing operational procedures. Skilled in timeline management and enhancing team productivity through effective organization. After a planned career pause to focus on family, I am seeking to re-enter the workforce with a refreshed focus, adaptability, and a continued commitment to high-quality clinical research.
Overview
8
8
years of professional experience
Work History
Manager, Clinical Remote Study Start-Up
Firma Clinical Research
Chicago, IL
05.2017 - 09.2019
- Managed planning, coordination, and execution of study, country, and site-level startup activities for remote visit services.
- Directed and supervised start-up forecasts, goals, and critical timelines, and conducted strategic assessments to address potential challenges.
- Established study start-up (SSU) objectives and clarified team tasks during the SSU process.
- Provided input into budget planning, timelines, performance metrics, and resource recommendations for study start-up execution.
- Developed and finalized strategic plans and documents customized to individual protocols, ensuring alignment with sponsor agreements, project timelines, and key milestones.
- Developed and delivered training for clinical site staff on remote visit services at domestic and international Investigator Meetings, enhancing site understanding and utilization of remote visit services.
- Developed and led comprehensive training sessions for internal study teams, prior to study activation.
- Organized teleconferences with sponsors, contract research organizations (CROs), and central laboratories to facilitate communication and collaboration.
- Evaluated team member performance through structured reviews to ensure alignment with organizational goals. for team members.
- Recruited and hired qualified candidates to fill open positions.
Remote Visit Associate
Firma Clinical Research
Chicago, IL
04.2016 - 05.2017
- Monitored goals and KPIs for remote visits, facilitating performance evaluations.
- Collaborated with internal directors and senior leadership to formulate strategies for remote visits and delivered presentations during prospective business engagements.
- Oversaw study start-up processes for new projects, ensuring timely completion of remote visit documentation and adherence to study timelines.
- Managed internal project management workbook, tracking timelines, forecasting costs, and controlling budgets for effective project oversight.
- Provided detailed monthly reports to senior management on project status and budget adherence.
- Supported contracts team with confidentiality agreements, master service agreements, and study-specific scopes of work.
- Reviewed protocols, lab manuals, pharmacy manuals, delegation logs, and electronic case report forms for compliance.
- Ensured proper electronic filing, maintenance, and distribution of documents to relevant team members.
Study Start-Up Specialist
GlobalCare Clinical Trials, Ltd
Bannockburn, IL
01.2016 - 03.2016
- Managed study start-up documentation timelines, ensuring on-time project initiation.
- Reviewed protocols, lab manuals, and pharmacy manuals to verify compliance with regulatory requirements.
- Evaluated delegation logs and electronic case report forms (eCRFs) for accuracy and adherence to protocol.
- Developed training manuals for home health nurses on GCP/ICH guidelines, IATA, HIPAA, and Good Documentation Practices, enhancing compliance and operational readiness.
- Finalized source documentation for data collection during in-home study visits.
- Supported management of contractual scope modifications for ongoing projects, streamlining processes and maintaining project alignment.
Senior Clinical Trial Associate
GlobalCare Clinical Trials, Ltd
Bannockburn, IL
04.2014 - 12.2015
- Identified and trained home health nurses to ensure compliance with study procedures.
- Coordinated sponsor teleconferences to facilitate communication and updates for designated research studies.
- Participated in investigator meetings to discuss project progress.
- Oversaw pharmacy operations for direct-to-patient delivery via centralized facility.
- Prepared and negotiated contractual agreements with nursing agencies to secure necessary resources for studies.
Clinical Trial Associate
GlobalCare Clinical Trials, Ltd
Bannockburn, IL
10.2013 - 04.2014
- Executed quality control of visit documentation, ensuring timely distribution of approved documents to clinical sites within two business days after remote visits.
- Maintained electronic study trackers for assigned research projects, enhancing data accuracy.
- Scheduled all visits according to physician orders and ensured protocol compliance.
- Monitored supplies and laboratory kits inventory for in-home study visits, facilitating timely replenishment across multiple studies and countries.
Clinical Trial Assistant
GlobalCare Clinical Trials, Ltd
Bannockburn, IL
04.2013 - 10.2013
- Supported project team during initiation, execution, and completion phases of studies, ensuring alignment with project goals.
- Coordinated meeting agendas and distributed minutes to sponsors and CROs, facilitating clear communication and collaboration.
- Reviewed and archived official study documentation per SOP guidelines, maintaining compliance and data integrity.
Data Administrator
CompleWare Corporation
North Liberty, IA
02.2012 - 04.2013
- Managed all data handling for clinical trials, prioritizing Phase II and III research on COPD and asthma.
- Directed data management department, overseeing team performance and study progression to ensure timely completion of clinical trials.
- Developed Data Management Plans and contributed to designing Electronic Case Report Forms.
- Collaborated with database team to establish data specifications and edit checks per protocol.
- Prepared comprehensive training documentation, ensuring real-time software access for stakeholders.
- Compiled weekly progress reports for sponsors, enhancing communication and project transparency through structured conference calls.
Data Analyst
CompleWare Corporation
North Liberty, IA
06.2011 - 02.2012
- Executed data queries to identify and rectify discrepancies, enhancing data accuracy.
- Facilitated internal data validation training for team members, improving overall data quality.
- Produced weekly study status reports for senior management, informing decision-making.
- Collaborated with data administrator on database clean-up and locking operations for protocols.
Education
Bachelor of Arts - Journalism And Mass Communication
The University of Iowa
Iowa City, IA05-2011
Skills
- Remote study coordination
- Project management
- Compliance monitoring
- Performance metrics
- Conflict resolution
- Training development
- Vendor management
- Key performance indicators
- Staff training
Timeline
Manager, Clinical Remote Study Start-Up
Firma Clinical Research
05.2017 - 09.2019
Remote Visit Associate
Firma Clinical Research
04.2016 - 05.2017
Study Start-Up Specialist
GlobalCare Clinical Trials, Ltd
01.2016 - 03.2016
Senior Clinical Trial Associate
GlobalCare Clinical Trials, Ltd
04.2014 - 12.2015
Clinical Trial Associate
GlobalCare Clinical Trials, Ltd
10.2013 - 04.2014
Clinical Trial Assistant
GlobalCare Clinical Trials, Ltd
04.2013 - 10.2013
Data Administrator
CompleWare Corporation
02.2012 - 04.2013
Data Analyst
CompleWare Corporation
06.2011 - 02.2012
Bachelor of Arts - Journalism And Mass Communication
The University of Iowa