First in Human, dose escalation oncology trialsVendor selection and management CRO oversight

Clinical research consulting.Clinical research contracting.

Clinical Trial Management from start up through closeout, including management of vendors, supplies, IMP, budgets, timelines

Independently serving as key point of contact in country for multiple studies o Responsible for study timelines including country and site selection, site activation, screening, enrollment database lock, etc. o Oversight of all site management team members and monitoring activities o Ensure Health of Study and Health of TMF from startup thru completion via site reports and performance metrics o Relationship development of health care providers and Dermatology KOLs in conjunction with Medical Affairs - Accountable for all activities of site related study execution of assigned studies - Accountable for on time and within budget study execution of assigned projects - Ensure audit and inspection readiness. Prepare and follow up on audits, CAPA preparation and implementation - Resource management for assigned team. Allocating resources in alignment with research goals, priorities, and study specific timelines - Acquisition, retention, performance management, and growth and development of talent

- Conduct clinical site qualification, initiation, interim and closeout visits. Ensure regulatory inspection readiness at assigned clinical sites.- CRA training and on-boarding - Monitoring visit report review and approval- CRA mentor- Conduct CRA training visits- Conduct CRA performance assessment visits- KOL site management- Member of study site audit preparedness teams- Designated Subject Matter Expert (SME) and trainer for Abbvie CTMS

o Responsible for study timelines including country and site selection, site activation, screening, enrollment database lock, etc.o Oversight of all site management team members and monitoring activitieso Ensure Health of Study and Health of TMF from startup thru completion via site reports and performance metricso Monitoring plan developmento Development of training presentations and responsible for CRA trainingo Provide input in cross functional study team as representative of Site Management & Monitoring (examples: Feasibility, Country/Site selection, Recruitment plans, EDC, eCRF creation, Risk Management, Study Timelines)

Conducted site visits to determine protocol and regulatory compliance, and prepared required documentationPerformed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products

Developed partnerships with clinical research sites for long term collaborations

• Serve as mentor/trainer for less experienced CRAs to assist with general and study-specific monitoring issues• Perform CRA evaluation visits• Clinical Trial Management tasks, including visit report review, site budget negotiations, vendor management, creation of study specific training presentations• Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data (monitoring plan, patient tracking forms, source document templates)• Development and review of Informed Consent forms (ICF)• Track study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status are kept current by the monitoring team• Perform Serious Adverse Event reconciliation and work with sponsor, study sites and CRAs to resolve discrepancies• Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines• Assist sponsor, study sites, and CRAs with audit preparation/responses and quality issues• Developed collaborative relationships with investigative sites, client company personnel and study vendors• Manage vendor-site interactions and resolve issues• Provide training to clinical investigators and site personnel• Maintain training and knowledge in GCP/ICH guidelines and FDA CFR• Utilize and review RECIST, CTCAE, IWG response assessments, WHO classifications, HRQOL, IPSS

-Conduct pre-study, initiation, monitoring, and close-out visits (80% travel) according to SOPs and GCPs-Meet with KOL’s and perform site assessments for clinical trial participation-Perform clinical study presentations including review of clinical trial protocols-Responsible for completion of visit reports and maintenance of study related databases-Regulatory document review-Adverse Event and Serious Adverse Event reporting and follow up

Conducting research in the identification and characterization of novel oncogenes in human carcinogenesis, primarily focusing on gastric and esophageal cancers-Writing scientific papers on research findings for publication-Protocol writing and review-Pharmacogenomic analysis of human and animal tissue samples and cell lines-Inventory and clinical database management-Monitor and maintain all health and safety information including Adverse Events for in vivo research trials according to IACUC and FDA requirements-Attend various local, regional, and national scientific conferences to collect, analyze and interpret new research. -Build professional relationships with key opinion leaders (KOL’s) in areas of mutual scientific interest with the purpose of developing new ideas and collaborating on research projects-Utilizing online scientific databases (PubMed & CGAP) to keep current on the latest research findings and to enhance laboratory research experiments and procedures-Training and oversight of research support staff-Planned and conducted scientific experiments for the purposes of in depth genetic analysis -Utilizing state of the art genetic analysis techniques including Pyrosequencing, SNP analysis, Microarray, Polymerase Chain Reaction (PCR), Western Blot, DNA methylation Analysis, Serial Analysis of Gene Expression (SAGE)

Studying the effects of inflammatory diseases including Ulcerative Colitis and Crohn’s Disease on gastrointestinal transportation and absorption mechanisms-Developed presentations for peers in the medical community-Reviewed current scientific publications to stay abreast of the latest research findings, laboratory techniques, practices and regulations-Maintained OSHA regulations for laboratory safety-Planned and conducted scientific experiments involving various techniques