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Clinical Project Manager

Location:
New York, New York, 10011, United States
Posted:
August 10, 2018

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Resume:

Joseph A. LaValle

*** *. **** **., *** *K, ac6mmh@r.postjobfree.com

New York, NY 10016 303-***-****

PROFESSIONAL EXPERIENCE

Flatiron Health, New York, NY

Lead, Research Quality & Compliance Oct 2017 - Jul 2018

● Optimized adverse event reporting workflow and trained staff to mitigate compliance risk

● Designed, implemented, and maintained a new automated mechanism to track employee training

● Directed investigation of corrective/preventive action plan and ensured timely closure of objectives

● Planned and executed an internal audit with cross-functional teams focused on process improvement

● Drove protocol submission lifecycle (drafting, collaborative review, IRB submission, and tracking)

Memorial Sloan Kettering Cancer Center, New York, NY

Regulatory Research Project Coordinator, Head & Neck Oncology Feb 2016 – Oct 2017

● Oversaw regulatory submissions of 8+ clinical trials; implemented 2 tracking systems to increase transparency

● Supervised the regulatory health of 25+ clinical trials and provided guidance to 7 study coordinators

● Ensured project deadlines were exceeded and pharmaceutical/CRO relationships were maintained

● Collaborated with sponsor/CRO and Principal Investigator to develop Informed Consent documents

● Identified operational inefficiencies and recommend procedural improvements to enhance compliance

● Awarded MSKCC’s ‘Values in Action – Relentless’ distinction during staff appreciation week

Research Study Assistant II, Gastrointestinal Oncology Jun 2012 – Feb 2016

● Oversaw enrollment, study conduct, and correspondence for two phase 1B/2 clinical trials (60+ patients)

● Analyzed toxicity/survival data for 39 patients leading to co-authorship of phase II trial

● Coordinated weekly meeting and presented study progress/updates to MDs, nurses, and research team

● Led audit preparation seminar for department staff meeting, 300+ in attendance

● Spearheaded joint pilot program for institution-wide template standardization initiative

● Mentored 5 junior study coordinators; supervised onboarding and professional development

Research Study Assistant I, Gastrointestinal Oncology Jun 2011 – Jun 2012

● Managed 3+ simultaneous, industrially-sponsored therapeutic pancreatic cancer clinical trials

● Extracted essential data from patient EMR; Fluent in multiple EDC systems (MediData RAVE, Inform, etc.)

● Orchestrated efforts between physicians, nurses, and staff to ensure protocol compliance

EDUCATION

Colgate University, Hamilton, NY M ay 2011

Bachelor of Arts: Biology

Senior Research Project: Functional analysis of the small dog variant of Growth Hormone Receptor Pablo de Olavide, Seville, Spain A ug – Dec 2009

Spanish Immersion Semester

COMPETENCIES

● Problem Solving ● Project Management ● Clinical Trials ● Staff Training

● Collaboration ● Quality Assurance ● Oncology ● Data Management

ACTIVITIES/INTERESTS

● Marathoner, Chinatown seafood, Colorado 14ers, Ice Hockey, Home improvement, Spanish haggling



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