Detail Oriented Receptionist
Resume:
CATHY C. SCALZO
FAIR HAVEN, NEW JERSEY 07704-3238
732-***-**** home
732-***-**** cell
********@*******.***
EMPLOYMENT
MERCK PHARMACEUTICALS, Rahway, New Jersey November 2012 – January 2024
Lead Clinical Scientist, Oncology May 2018 – January 2024
Clinical Scientist, Oncology February 2016 – April 2018
Clinical Development Scientist, Oncology January 2015 - January 2016
Senior Clinical Scientist/Senior Clinical Safety Scientist November 2012 - December 2014
(Consultant through Joulé Clinical Staffing Solutions/System One)
Conducted clinical studies with emphasis on protocol/therapeutic area specific activities including data management deliverables, protocol level plans, database updates, meeting materials preparation, listing reviews, communication plans, safety and medical monitoring, preparation of status update reports and study close-out activities.
Facilitate Medical Monitoring Meetings.
Actively participate in the development of procedural manuals and training materials.
Contribute to clinical study reports, regulatory agency updates and other clinical and regulatory documents.
Trained/Mentored Clinical Safety Scientists.
Interacted with internal and external stakeholders in support of clinical trial objectives.
Accomplishments:
Developed processes to ensure quality and consistency in document review.
Developed processes to meet changing department needs and increased efficiency and effectiveness.
NOVARTIS PHARMACEUTICALS, East Hanover, New Jersey January 2009 – March 2011
Clinical Research Scientist II/Study Manager
(Consultant through The Cambridge Group (now Valesta Clinical Research Solutions)
Developed the central and reference laboratory components to clinical protocols.
Executed contracts and documentation required to set up central lab procedures.
Provided training manuals for global clinical sites and developed study-specific training material.
Provided on-going support to global sites.
Devised appropriate solutions to satisfy both ethical concerns and study objectives.
Contributed to and reviewed global protocols.
Ensured all deliverables were met in accordance with budget, timelines and Standard Operation Procedures.
Accomplishments:
Worked on thirty-two global studies concurrently as a consultant.
MDS PHARMA SERVICES (now Celerion), Neptune, New Jersey July 2006 – July 2008
Clinical Study Manager
Set-up, managed and executed multiple pharmaceutical trials simultaneously from initiation to completion.
Lead study teams including subject recruitment, data management, drug processing, sample collection, processing, storage and shipment as well as clinic, laboratory and pharmacy personnel.
Facilitated and actively participated in investigator meetings.
Developed, implemented, and reviewed protocols, informed consents and case report forms.
Coordinated interdisciplinary activities involving study start-up, subject recruitment, drug handling, sample collection, case report form development, database set-up, clinic and clinic event set-up, query resolution and regulatory document filing.
Trained and supervised clinic staff to ensure consistency and compliance with protocol requirements.
Reviewed, reported and addressed urgent issues including adverse events and serious adverse events in collaboration with investigator.
Ensured compliance and adherence to federal and local regulatory guidelines, including, but not limited to International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs), Health Care Compliance, Health Insurance Portability and Accountability Act (HIPAA), and Standard Operating Procedures (SOPs).
Monitored and resolved regulatory document and data clarification discrepancies.
Accomplishments:
Lean Six Sigma.
Successfully managed to completion over 10 Phase I studies.
Experienced in various therapeutic areas including cardiovascular, diabetes, gastrointestinal, Human Immunodeficiency Virus (HIV), infection, obesity, oncology, pain management.
EASTER SEALS SOCIETY OF NEW JERSEY, Eatontown, New Jersey April 2005 - January 2006
Human Resources Representative
Performed full-cycle recruitment, including sourcing, interviewing, selection, background checks, credential verification, and salary negotiations for six New Jersey counties.
Provided employee relations, employment counseling and conflict resolution.
Accomplishments:
Independently designed and implemented screening and interview scripts to assure adherence to all applicable laws and regulations.
Filled over 100 positions in six months.
Identified, investigated and proposed new tools; researched and targeted industry-specific websites.
PRA INTERNATIONAL, Eatontown, New Jersey September 1998 - February 2005
Clinical Data Coordinator April 2003 – February 2005
Edited and reviewed Case Report Forms for human clinical pharmaceutical trials Phases I - IV.
Generated, reconciled, reviewed and tracked data discrepancies within clinical databases.
Interacted with investigational site personnel and/or Clinical Research Associates during the query resolution process.
Performed quality control review of critical variables and d
Defined and followed up on milestones and timelines.
Accomplishments:
Reduced discrepancies by improving and implementing clear and precise queries.
Met or bettered all assigned timelines.
Corporate Recruiter August 2000 – April 2003
Corporate Recruiting Assistant II September 1999 – August 2000
Project Assistant September 1998 – September 1999
Performed full-cycle recruitment, i.e. sourcing, interviewing, selection, background checks, credential verification, salary negotiations; ensured all actions were in adherence to Equal Employment Opportunity (EEO), Americans with Disabilities Act (ADA).
Supervised and mentored junior and administrative staff; lead team in performance evaluations.
Promoted services by attending national Medical and Health related conferences, seminars and tradeshows, advertised using specialized job boards and industry-specific publications.
Identified, investigated and proposed new recruiting tools, researched and targeted industry-specific websites resulting in drastic increase in targeted and qualified candidate pool.
Accomplishments:
Performed investigator and site selection for clinical trials Phases II-IV.
Assisted in the establishment of, and successful population and utilization of, BrassRing candidate database creating a centralized pool of qualified candidates, which eliminated candidate duplication.
Independently designed and implemented screening and interview scripts to assure adherence to all laws and regulations.
Organized all relocation, travel, lodging and transportation needs for candidates.
Conducted reference checks and degree verification for potential hires.
Assisted with study start-up, creating regulatory packets and maintaining regulatory document library.
Assisted in investigator meeting preparation and interacted with investigative site personnel and CRAs.
Created spreadsheets and distributed study-related regulatory documents.
EDUCATION
MONMOUTH UNIVERSITY, West Long Branch, New Jersey
Master’s Degree in Psychological Counseling – May 2003
Baccalaureate Degree in Psychology – December 2000
APPOINTMENT
Notary Public - State of New Jersey
PUBLICATIONS AND PRESENTATIONS
Stapley, J.C. & Scalzo, C.C. (2000). Emotional Intelligence and Adjustment to College. Poster Presentation at the Biennial Meeting of the Conference on Human Development, April, Memphis, Tennessee.
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