Yyyyyy x. yyyyyy

2155 Judge Fran Jamieson Way #0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx ● abc@xyz.com

Clinical Studies ~ Scientific Research ~ Project Management ~ Regulatory Compliance

         Solid background in project leadership, patient recruitment, site visit coordination, data management, fostering relationships with pharmaceutical companies and CROs, leading Corrective and Preventive Action (CAPA) for clinical trials, and monitoring for serious adverse events (SAEs) and adverse events (AEs).

         Highly regarded for strong consultative, leadership, training, analytical, and troubleshooting abilities.

         Extremely well-versed in lab techniques, statistical data collection and analysis. ICD-9 audits, gap analysis, root cause analysis, variance analysis, clinical documentation, and clinical quality assurance.

         Adept at developing and managing budget and operating plans to ensure efficient facility operations.

         Demonstrated expertise in Good Clinical Practice (GCP) CRF, DCF, EDC, and safety compliance.

Self-employed, 2015 Present

Principal Consultant / CEO / Founder

         Provide highest-quality medical equipment and clinical consulting services on a global scale.

         Partner with cross-functional teams to plan, implement, evaluate, and deliver projects spanning telemedicine, clinical quality assurance, policy development, and access to medical care.

         Currently orchestrating projects serving West Africa including construction of 200-bed orphanage facility, public health initiatives (i.e. HIV awareness, clean water), and renewable energy solutions such as construction of 50 solar homes.

ProPhase, New York, NY, 2014 2015

Clinical Quality Assurance Administrative Officer

         Spearheaded clinical QA projects encompassing data collection, trend analysis, bids, purchase requisitions, database administration, budget compliance, progress tracking, and report writing.

         Assembled critical validation lifecycle documentation for equipment, processes, and facilities such as IQ, OQ and PQ protocols, SOPs, change controls, and user/functional/design specifications.

         Contributed to creation of algorithms to identify actionable patient-specific opportunities for strengthening compliance with best clinical practice.

         Calculated estimates for executive team, oversaw validation vendors, maintained quality systems, guided project workflow, and improved accuracy of budgeted hours to fuel company capacity and profit.

         Provide cGxP compliance interpretation, consultation, and training to elevate quality of research.

Yale Cancer Center, New Haven, CT, 2011 2014

Interim Project Manager / Data Manager

         Governed clinical study documents including clinical protocols, informed consent forms, study plans, case report forms, source documents, monitoring plans, data management plan, and project management plan.

         Exhibited outstanding talents throughout the project lifecycle from defining timelines and tracking status, to communicating progress to stakeholders and providing metrics and benchmarking reports.

         Resourcefully introduced data collection tools to improve source collection, reconciled central laboratory vendor data, and effectively resolved problematic data identified during review activities.

         Ensured all clinical trials confirmed to SOPs, FDA regulations, and ICH/GCP guidelines.

         Drove QA operations by tracking clinical CAPAs and following up with stakeholders for swift remediation.

         Collaboratively structured remediation plans as required to resolve protocol deviations.

         Formally awarded and recognized for vision and values related to team-building, clinical data quality assurance, and clinical trials office development .

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Bausch & Lomb, (Kelly Clinical Services), Rochester, NY, 2010 2011

Clinical Quality Specialist

         Delivered influential support to Global Clinical Operations department by reviewing, validating, and optimizing clinical QA for medical devices.

         Conducted gap analysis, performed comprehensive system and study GCP audits, and compiled audit reports featuring requests for CAPA to expedite and ensure compliance with SOPs and clinical quality plan schedule.

         Devised instructional materials for project team members and delivered training to clinical research professionals.

         Significantly boosted efficiency and quality of operations by steering Trial Master File project which converted files to electronic format.

         Prepared project-specific documentation, administered trial distribution agreements and investigational packaging agreements, relabeled activities, and successfully delivered audit-ready clinical trial package.

Hometown Urgent Care & Research, Dayton, OH, 2010

Research Coordinator

         Championed clinical trials for multiple pharmaceutical-sponsored phase II-IV studies on indications such as osteoarthritis, pain management, irritable bowel syndrome, bacterial conjunctivitis, migraine, shingles, community acquired pneumonia, ankle sprain in adolescents, and opioid studies.

         Applied sharp organizational skills toward overseeing regulatory documents, clinical trial manuals, data quality control, site initiation (SIV, PSSV) visits, facility tours, contract proposals, and financial disclosures.

         Trained, mentored, and coached medical assistants at five sites on recruitment procedures and reporting.

         Methodically submitted IRB and sponsor documentations for study approval and continuing review.

Prior Background:

Treasury Analyst, Colgate Palmolive

Industrial Engineer, Coopers & Lybrand

Bachelor of Science, Industrial Engineering, New York Institute of Technology, New York, NY

Professional Development:

Drug Development Process; CFR; ICH Guidelines; HIPAA (clinical studies); Study Initiation, Monitoring, and Closing; Good Clinical Practice; SOPs Monitoring Clinical Studies, Inc., achieved 100% on final exam

Cancer Clinical Trials Basics NIH

CFR 21 Part 312 & 812 Subpart C, D, G CFR 21 Part 11, 50

ExpertRating TQM Certification ● Project Management Certification

5S ● JIT ● Lean Six Sigma Black Belt (in progress)

Microsoft (Word, Excel, PowerPoint, and Access), C++, Oracle, CAD/CAM, COBOL, GPSS, MRP, SAS/STAT, SPSS, SAP, Reuters, Bloomberg, Hyperion, MediNous, OpenClinica 3.0, BioClinica CTMS, Centricity, TranSenda, HEDIS, MedDra, Documentum, SharePoint, DOS, ComplianceWire, HTML, Medidata RAVE, IVRS, eCRF, eDiary, AutoCAD

Regulatory Affairs Professional Society

International Society of Pharmaceutical Engineering

Society of Clinical Research Associates