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Clinical Research Quality Control

Location:
Brooklyn, NY
Posted:
February 21, 2024

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Resume:

LISA OGARET ASMAR

ADVANCING THOUGHT LEADERSHIP IN ONCOLOGICAL INNOVATION

DIRECTING WORLD-CLASS PHARMACEUTICAL RESEARCH OPERATIONS Driving Market-Leading Innovation Empowering Teams Optimizing Efficiency & Profitability

Inspirational & Collaborative Leadership Innovative Solution Provider Clinical Trials/Program Management

Building Strategic Partnerships Streamlining Workflows Solid Organizational & Analytical Skills

Communicating Effectively at All Levels Implementing Best Practices Quality Control & Regulatory Compliance Passion for Developing & Motivating Exceptional Teams that Exceed Goals & Deliver Outstanding Results EXEMPLARY LEADERSHIP directing industry-leading innovations that include development and implementaton of a groundbreaking Oral Chemotherapy Program and the building of new state-of-the-art clinical/research facilities. STRONG SCIENTIFIC & BUSINESS ACUMEN uniquely blending both business and pharmaceutical training, having earned a BS in Pharmacy and an MBA (Summa Cum Laude).

EXCELLENT COMMUNICATOR & RELATIONSHIP BUILDER fluently articulating complex scientific information appropriately tailored to both technical and non-technical stakeholders; actively cultivates and maintains strong relationships with colleagues, teammates, educators, industry professionals and key opinion leaders. ADDING SIGNIFICANT VALUE as an expert teambuilder and mentor, helping others succeed, instituting best practices and leveraging Lean methodologies to continually improve and optimize efficiency in support of mission-focused objectives. AWARD-WINNING PERFORMANCE Lead in award -Institute for Safe Medication Practices (ISMP) recipient of annual cheers award December 2021, acknowledged by receipt of notable recognition that includes the ASHP Award for Safety: Telepharmacy Model and the Pharmacy Excellence Award.

PROFESSIONAL EXPERIENCE

CITY OF HOPE, remote 2020-PRESENT

An NCCN research and treatment center for cancer and rare diseases Senior Manager, Clinical Research Content (Remote)

• Serving as Clinical Research Pharmacy Leader, working in collaboration with Principal Investigators, Disease Teams, Study Teams to oversee the development of comprehensive protocol-specific content.

• Navigates competing priorities to ensure work product and output are consistent with strategic goals of institution

• In the vertical of Clinical Cancer Research directing all conduct, oversight administration, work creation, implementation of Electronic Medical Record (EHR) functionality under the jurisdiction of Research Operations. Instrumental to the successful conduct of clinical research studies as managed within the EPIC EHR.

• Continual support and efforts with Key Opinion Leaders, Thought Leaders, Subject Matter Experts Clinicians to execute goals and algin future expectations as outlined

• Provides consistent leadership and direction to all Research Clinical Content development

• Ensures adherence to high-quality, standardized work practices

• Streamline Interdepartmental communication and effective collaboration with leadership and staff across multi-disciplinary clinical departments

• Motivates, monitors, models team performance to support clinical consistency and end goals of safe, quality service

• sponsible for talent seeking, hiring, orientation delegation, continual training

• Continual change management as deemed necessary by environmental or enterprise needed, such as current work from home model for entire department

• Continual collaborations within Department of Pharmacy Leadership to ensure Research and Standard of Care protocols and development in alignment

• Continual work within EPIC EHR to incorporate best practices based on most current upgrades

• Ability to pivot department workload as deemed necessary by leadership and other identifying goals

• Member of P&T, Medication Safety Committee, IRB, and other essential committees relevant to teams and enterprise success

• Current Project Include but not limited to -Institute for Safe Medical Practices (ISMP)-submission candidate for cheers award 2021; Medication Safety Officers Society Member-May 2021 Presentation for City of Hope linkedin.com/in/lisa-ogaret-asmar-abdien-38701192

774-***-**** ad3tg4@r.postjobfree.com

MOUNT AUBURN HOSPITAL, Cambridge, MA 2017 – 2020

Teaching healthcare system affiliations with Harvard Medical School. MANAGER-LEAD ONCOLOGY SPECIALIST

Full accountability to develop/maintain clinical practice with patient care service in collaboration with medical and nursing personnel. Select pharmacologic agents and design regimen to maximize therapeutic benefits.

Act as Subject Matter Expert to other healthcare professionals in response to evolving issues with patients with cancer.

Provide managerial responsibilities for operations of Hematology/Oncology satellite.

First to develop and establish Oncology/Hematology Multidisciplinary Pharmacy Review Committee

Responsible for EPIC and Varian EMR builds specific to Hematology Oncology Department

IRB member

Lead Investigational Pharmacist-first to implement electronic ordering in the organization, EPIC ERX builds, Varian Builds specific to clinical trials

Educational In service provided on an as need basis for SOP or changes in practice

Continual efforts for change management as deemed such as work from home current situation

Responsible for piloting dose rounding in hematology/oncology –projected savings of $ 500,000 per year-this model to be extrapolated to in house use for applicable agents

HAZMET policy-USP 800

Responsible for developing, implementing and educating staff on Policy and Procedures as it relates to the department

Management of Hematology/Oncology Pharmacy Staff

Collaboration with Pharma and Biotech companies to provide educational in-service to staff

Ongoing cost savings incentives-Pharmacy & Therapeutic Committee-replacement of medications with bio-similar agents when applicable (ie. Remicade to Inflectra, Neupogen to Zarxio)

Creation of focus group to consistently counsel patients with oral chemotherapy, biotherapy, immunotherapy in clinic and follow up at home to ensure patients are safely taking medications as prescribed.

Maintaining compliance of required regulatory agencies, keeping in line with USP 797 and coming USP 800 guidelines, GMP practices

CITI training in date

Auditing of charge reports on monthly basis to ensure accuracy and compliance of billing DANA FARBER CANCER INSTITUTE – AFFILIATE OF HARVARD MEDICAL SCHOOL, Boston, MA 2015 – 2017 World leader in providing adult and pediatric cancer treatment while developing tomorrow’s cures through cutting-edge research. RESEARCH PHARMACY OPERATIONS MANAGER – ONCOLOGY/HEMATOLOGY/PEDIATRIC (2016-Present) Direct investigational research operations developing, administrating, organizing, streamlining & successfully implementing all pharmacy operational activities. Build, supervise, mentor and direct top-producing teams; institute and implement process improvements and quality enhancements to optimize performance.

Manage operational workflow involving over 800 research protocols including Phase I first in humans.

Conduct recruitment, selection, and staff orientation including preceptor of Northeastern University Coop students.

Document quality activities and achieve metrics to meet appropriate regulatory authority requirements.

Implement collaborative communication and provide drug information through in-service education & daily support.

Align clinical trials to mimic commercial process of dispensing within data base environment.

Champion of Lean methodology to continually improve and optimize efficiency of medication management.

Involvement in any FDA audits for approval of new therapies

Involvement in Pharma audits and count resolution

Knowledge and ability to work at high level with IVRS or IXRS systems of ordering or accountability

NCI protocols high level involvement and knowledge RESEARCH PHARMACIST – ONCOLOGY/HEMATOLOGY (2015-2016) Managed clinical review and operational development of new investigational drug research protocols including Phase I, II, & III studies. Identified and rectified inconsistencies in protocol review with organizational standards.

Developed drug order sets establishing ordering protocols aligned with computerized system.

Oversight of required regulatory audits for clinical trials development assuring compliance with FDA, Sponsor & Pharma.

Managed over 800 clinical trials overseen by IDS staff involving medication.

Protocols included NCI, NIH, Pharma, PI initiated and others. LISA OGARET ASMAR

774-***-**** ad3tg4@r.postjobfree.com

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YALE NEW HAVEN HOSPITAL, New Haven, CT 2014- 2015

Sixth largest hospital in U.S. with $125 million pharmacy budget. MANAGER OF PHARMACY SERVICES – SMILOW CANCER CENTERS Led global product and services portfolio for chemistry, instrumentation and informatics. Headed team of dedicated product marketing managers charged with developing and implementing short and long-term take share strategies. Directed recruitment, selection, orientation and performance of staff members, assuring talent was being fully utilized to maximum efficiency.

Provided oversight and operational management of 15 remote care centers throughout Connecticut, streamlining processes and establishing consistency aligned with best practices; NCCN, NCI approved sites. MARLBOROUGH HOSPITAL, Marlborough, MA 2000 – 2014

Community hospital providing a wide range of inpatient and outpatient medical, surgical and ancillary services & emergency care. ONCOLOGY PHARMACIST - LEAD

Directed clinical and operational components of Cancer Care Center. Assured delivery of accurate and comprehensive patient-specific drug information and provided educational services to clients and healthcare team. Monitored therapy and consulted with other professional providers.

Integral part of Planning & Design Committee for Marlborough Hospital Cancer Center.

Served as Project Lead in development and build of new state-of-the-art facility in Old Saybrook, CT.

Raised pharmacy standards, continually striving to provide improvements in clinical care systems.

Headed innovative Oral Chemotherapy Program to better serve patients while assuring patient safety.

Instrumental in winning QOPI Site Award certifying commitment to delivering the highest quality of cancer care. U-MASS/MEMORIAL HEALTH CARE, Worcester, MA 1991 - 2000 Largest health care system in Central Massachusetts offering region’s most sophisticated medical technology and support. ONCOLOGY PHARMACIST

Provided drug information through in-service education and daily support for pharmacy department, hospital clinical staff, medical residents and medical staff consultation with patients and families. Oversaw distributive department functions including order interpretation and modification.

Initiated clinical pharmacy standards related to oncology pharmacy including clinical trials program.

Developed and implemented clinical treatment guidelines, protocols, formulary changes and clinical pathways as approved by appropriate committees.

Guest Lecturer at U-Mass Medical School – Graduate School of Nursing (1992-1996)

Introduction to Pharmaceutical Care of Asthma, Cough & Cold and Allergic Reaction Support.

Review & Identification of Cause, Symptoms & Overall Treatments. EDUCATION AWARDS & HONORS COMMITTEE APPOINTMENTS LICENSURE MASTERS IN BUSINESS ADMINISTRATION, Anna Maria College, Paxton, MA GPA: 3.97 –Summa Cum Laude

BACHELOR OF SCIENCE - PHARMACY, Northeastern University, Boston, MA Institute of Safe Medical Practices (ISMP) Cheers Safety Award- City of Hope -December 2021 AWARDS & HONORS

Institute for Safe Medication Practices-Leader of recipient Annual Cheers award December 2021 Pharmacy Excellence Award 2014 QOPI Site Award – Yale 2014 ASHP Award for Safety: Telepharmacy Model – Yale 2014 Patient Safety Award Nominee 2013 SPECIAL COMMITTEE APPOINTMENTS

Clinical Trials Rapid Activation Consortium (CTRAC) 2020-Present MD Anderson Lead Medication Safety Officers Committee 2020-Present

Investigation Review Board Member 2015-Present Scientific Review Board Member 2015-Present Lead: Oral Chemotherapy Program 2014 Lead: New Site Cancer Clinic Development & Build – Old Saybrook, CT 2014 Planning & Design of Marlborough Hospital Cancer Center 2011-13 Pharmacy & Therapeutics Member 2000-14 PROFESSIONAL LICENSURE: MA & CT Pharmacy Licenses



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