Francine Kloszewski has over 28 years of experience in the pharmaceutical industry, with expertise in managing clinical trials from Phase 1 through Phase 3. She has a strong track record of meeting project timelines and deliverables. Her experience includes managing studies across various therapeutic areas for companies such as Worldwide Clinical Trials, inVentiv Health Clinical, RPS, Adolor Corporation, and Sanofi-Aventis.

1. F. High CV; 07 July 2016
Francine Kloszewski High
2323 Morgantown Road
Reading, PA 19607
(610) 937-1946 (M)
(610) 401-0538 (O)
(610) 777-7985 (H)
phoodgoddess@gmail.com
SUMMARY
Twenty-eight (28) years of experience in the Pharmaceutical industry. Twenty-five (25) years of experience in all
aspects of clinical trial operations. Expertise in Phase 1, 2, and 3 studies. Strengths include strong work ethic,
organizational skills, flexibility with changing priorities, excellent written and oral communication, problem
solving, and motivating teams.
PROFESSIONAL SKILLS SUMMARY:
 Ability to manage complex clinical trials with responsibilities encompassing project team
(domestic/international) coordination, GCP compliance, and action plan development.
 Works in a matrix environment; assures all project tasks are completed according to approved
schedules/timelines (i.e. average time between date of last patient out and database lock).
 Conducts regular study team meetings ensuring minutes and action plans are prepared and circulated.
 Reviews and manages vendor/CRO/study site contracts, budgets, proposals and communications.
 Documented track record of meeting or exceeding defined project deliverables relating to schedule
completion, budget management, and protocol requirements.
 Managed studies in the following therapeutic areas: Oncology, CNS, Pain, Endocrine, Diagnostic
Imaging, and Immunology
Worldwide Clinical Trials April 2015 to July 2016
Clinical Research Manager
Manage Phase 1a start-up in ovarian cancer and Phase 2 breast cancer oncology studies. Responsible for all
aspects of clinical trial management including CRA and site management, maintaining deliverable timelines for
sponsor, issue escalation, oversight and maintenance of both paper and electronic Trial Master Files as well as the
Clinical Trial Management System, timely review of monitoring visit reports, management of sponsor budget and
scope changes, management of site budget, vendor management, etc.
inVentiv Health Clinical Jul 2012 to Mar 2015
Clinical Research Manager
Manage Phase 1, Phase 2 and Phase 3 studies. Manage Phase 1 studies in bioequivalence/bioavailability, dose
escalation, and HAL (Human Abuse Liability). Manage Phase 2b study in Schizophrenia and Phase 3 global study
in pediatric pain. Experienced on working with Schedule 2 controlled substances and FDA requirements for
shipping, handling, and storage. Responsible for all aspects of clinical trial management including CRA and site
management, maintaining deliverable timelines for trial sponsor, oversight of Trial Master File (TMF), timely
review of monitoring visit reports, management of sponsor budget and scope changes, management of site
budget, vendor management, meeting sponsor-specific requirements for timely review of SOPs, timely
maintenance of the TMF, study management in the sponsor Clinical Trial Management System (CTMS), etc.
RPS (Research Pharmaceutical Services) Jul 2010 –Jun 2012
Clinical Trial Project Manager
Managed Phase 3 clinical trials in primary immunodeficiency disease (US) and clinical trial in daytime sleepiness
due to traumatic brain injury (global). Ability to effectively interact with clients to deliver study milestones
efficiently and on time.
 Effectively managed interim and close-out of discontinued global TBI study

2. F. High CV; 07 July 2016
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 Effectively met time line of “rescue” US PID disease study through first major data interim analysis
 Coordinate domestic/international study teams for study start up, interim, and study close-out, met all
sponsor requirements for global study including investigator payments, TMF, and study drug
reconciliation.
 Managed CRA staff, reviewed Monitoring Visit Reports ensuring site issues were followed and resolved,
conducted study team meetings between CRAs and sponsor CTM, prepared and distributed meeting
minutes, ensured team members followed up on action items.
 Work closely with CRA staff and sponsor to prepare and respond to findings of QA site audit and site
preparedness for FDA/EMEA audits.
ADOLOR CORPORATION May 2008 – Jun 2010
Clinical Trial Program Manager
As Lead Program Manager for the Adolor DELTA products, supervised and managed 5 US Phase 1 studies with
results delivered on time to start Proof-of-Concept (POC) Phase 2 study. Managed Phase 2 POC study and met
time lines for study completion.
 Responsible for day-to-day operational management from study start-up to CSR
 Conducted feasibility and site selection
 Management of a CRO and vendors, lead Study Program Team meetings (publish minutes and ensure
follow-up to action items) coordinating in-house activities with sponsor departments, managed program
budget, and reported study progress.
 Prepared source documents for site utilization
 Collaborate with Clinical Data Management on CRF (Case Report Form) design and generation of edit
checks
 Responsible for pre/post IRB ICF review and approval in accordance with company SOPs.
 Review and submission of site advertising to IRB.
 Reviewed and approved Clinical Monitoring Plan prepared by CRO
 Reviewed Monitoring Visit Reports and ensured follow-up and resolution of issues
 Site/CRO contact for protocol/medical issue resolution
 Provided protocol clarification to site questions, maintained FAQs
SANOFI-AVENTIS Jul 1988- Feb 2008
Sr. Clinical Trial Project Leader 2005 – 2008
Responsible for clinical operation of Phase 2b and Phase 3 CNS trials. Managed a Phase 3 trial submitted for
NDA submission for Eplivanserin (Ciltyri).
 Reduced screen failure rate by 20% through identification of site recruitment practices and implementing
process improvement by developing standard guidelines for screening potential trial subjects
 Met management challenge to reduce time from last subject visit to database lock of paper-based CRFs
from 8 to 4 weeks; encouraged staff ownership of initiative through planning sessions, weekly status and
trouble-shooting meetings, and forging close working relationship with data management based abroad.
 Piloted study for EDC
 Managed 4 CRAs and 1 CTA
Sr. International Clinical Trial Manager (ICTM) 2002 – 2005
 Lead ICTM for 5 Phase 1 clinical trials to support clinical development of a new oncology agent.
Coordination and oversight of study team meetings and managed global budget.
Clinical Research Manager I 2000 - 2002
Management of two pivotal Phase 3 Colorectal Cancer Clinical Trials to support Eloxatin NDA submission
 Supervised staff of 8 CRAs, 4 CTAs, and Safety Officer
 Met time lines for FDA submission
 Eloxatin approved for second line treatment of colorectal cancer 20August 2002

3. F. High CV; 07 July 2016
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Clinical Research Associate I- III 1993 - 2000
Responsible for Phase 1, 2b, and 3 oncology, CNS, and diagnostic imaging studies.
 Performed all tasks associated with study startup; conducted qualification, initiation, routine monitoring,
and close-out visits
 Collaborated on protocol writing and CRF design
 Presented protocol, conducted CRA and Study Coordinator training at Investigator Meetings.
 Negotiated investigator budgets
 Drafted ICF template, reviewed pre-and post-IRB ICF for compliance with company SOPs
 Prepared source documentation for site utilization
 Tracked study drug usage at sites and responsible for re-order
 In-house site contact during FDA inspection.
 Lead CRA on trial conducted for NDA submission for Elitek, approved in 2002 for treatment of TLS in
pediatric patients
Clinical Data Coordinator 1991 - 1992
Responsible for tracking, coding, and maintaining electronic and hardcopy databases of clinical data; identify and
track data discrepancies and resolutions. Participated in data review of Visipaque (Iodixanol) planned for
submission in 1992; Visipaque was subsequently submitted by Nycomed in 2006.
Research Scientist 1988 – 1991
Oncopharmacology/Virology Department: Set up a cellular assay using immunofluorescent analysis by flow cytometry for
screening of novel antisense compounds.
Genetic Toxicology Department: Set up and organize the Genetic Toxicology laboratory according to GLP. Adapted and
validated the standard micronucleus test for analysis by flow cytometry.
EDUCATION AND TRAINING
BA Biology
University of Rochester
500 Wilson Blvd
Rochester, NY 14627
1985
AAS Liberal Arts
Monroe Community College
1000 E Henrietta Rd
Rochester, NY 14623
1978
MEMBERSHIPS
ASCO
SoCRA
REFERENCES AVAILABLE UPON REQUEST

4. F. High CV; 07 July 2016
4
PUBLICATION ADDENDUM:
Abstracts: Clinical Research
S. Goldman, J. Holcenberg, J. Finkelstein, R. Hutchinson, S. Kreissman, L. Johnson, J. Grabicki, F. High, E.
Harvey and M. Cairo. Lower Incidence of Elevated Creatinine Hyperphosphatemia and Hypocalcemia in
Pediatric Patients Treated with SR29142 Vs. Allopurinol for Acute Tumor Lysis. Presented at the American
Society of Hematology Fortieth Annual Meeting, Miami Beech, FL, December 4-8, 1998.
Abstracts: Laboratory Research
1. Kathryn Kross, Francine Kloszewski, Paul F. Cavanaugh, and Edmond D. Kloszewski. Quantitative Analysis
of Human Papillomavirus Virus Type 16 E7 Protein by Flow Cytometry and Image Analysis. Presented at the
Coulter Symposium: Hematology, Cytometry, and Chemistry, Boston, MA, May 7-8, 1991.
2. Romano, P.J., Houck, J., Bartholomew, M., Smith, P.J., Kloszewski, F., Vesell, E.: Do HLA Antigens Influence
the Risk of Head and Neck Cancer? American Society for Histocompatibility and Immunogenetics, 17th
Annual Meeting, October 1991.
3. Romano, P.J., Bartholomew, M, Kloszewski, F., Stryker, J., Houck, J., and Vesell, E.: Do HLA Antigens
Influence Resistance to Lung Carcinoma? American Society for Histocompatibility and Immunogenetics, 15th
Annual Meeting, Toronto, Canada, September 17-21, 1989.
4. S. Wormsley, F. Kloszewski, J. Peter, R. Dawkins. Anti-neutrophil cytoplasm antibodies (ANCA) in systemic
vasculitis: Clinical utility of quantitation by flow cytometry. Presented at the First International Conference on
ANCA Copenhagen, January 1988 and at the XVI Western Regional Meeting of American Rheumatism,
November 5-6, 1987.
5. S. Swetavage, P. Lopez, F. Kloszewski, D. Mosier, R. Riblet: FACS and Flow Cytometry: New probes,
applications in immunology, genetics, and molecular biology. Presented at the FACS User's Meeting,
University of San Francisco, Lone Mountain Campus, August 10-12, 1983.
6. Romano, P.J., Bartholomew, M., Kloszewski, F., Stryker, J., Houck, J., Vesell, E. Studies on the Association
between HLA Antigens and Lung Carcinoma. Progress in Immunology III, Duke University, Durham, North
Carolina, 1989.
Papers: Clinical Research
Goncalves, P H; High, F; Juniwicz, P; Boerner, S; Li, J; Shackleton, G; LoRusso, P: Phase I dose-escalation study
of thioxanthone, SR271425, administered intravenously once every 3 weeks, in patients with advanced
malignancies Investigational New Drugs 26:347-354, 1 May 2008.
Papers: Laboratory Research
1. Houck, J., Romano, P.J., Bartholomew, M., Smith, P.J., Kloszewski, F., Vesell, E.: Do Histocompatibility
Antigens Influence the Risk of Head and Neck Carcinoma? Cancer, 1992; 69:2327-2332.
2. Romano, P.J., Bartholomew, M., Smith, P.J., Kloszewski, F., Stryker, J., Houck, J., Vesell, E. HLA Antigens
Influence Resistance to Lung Cancer. Human Immunology 31: 236-240, 1991.
3. P. Romano, A. Lipton, H. Harvey, G. Guidice, F. Kloszewski, L. Witkowski, M. Downing. Immunological
monitoring studies in advanced cancer patients treated with recombinant human gamma interferon (INF-4A).
Molecular Biotherapy, vol. 1, No. 4, 1989.