Experience

Argenta

• New Zealand
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Senior Clinical Research Associate

  • Aug 2023 - Present

  Senior Clinical Research Associate at Argenta Clinical R&D -Serves as the main communication contact between Argenta Clinical and study site personnel -Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies -Project Management -Lead Clinical Research Associate -Meets and collaborates with Sponsors and Project Managers in the development of study protocols, data capture forms, study materials and assessing case evaluability at the… Show more Senior Clinical Research Associate at Argenta Clinical R&D -Serves as the main communication contact between Argenta Clinical and study site personnel -Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies -Project Management -Lead Clinical Research Associate -Meets and collaborates with Sponsors and Project Managers in the development of study protocols, data capture forms, study materials and assessing case evaluability at the conclusion of the study -Track adverse events -Ensure enrollment objectives are attained per study timelines -Manage and monitor study drug inventory -Coordinates and conducts GCP, ICH, and VICH -Review study records and data for Quality Control -Ensure protocol compliance -Timely monitoring of electronic data capture data entry systems -Assist study sites with issues/concerns -Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel -Travel to study sites to qualify, initiate and close out clinical study sites -Train site personnel on protocol, GCP, and EDC -Site recruitment -Assist in marketing strategies -Working knowledge of data management, quality control and quality assurance -Strong analytical thinking and problem-solving skills -Leadership, knowledge, and experience that results in ability to make decisions for the team

• Clinical Research Associate II

  • Dec 2020 - Aug 2023

  Clinical Research Associate II monitoring Veterinary Clinical Trials under GCP and VICH -serve as main contact person between clinical study sites and Argenta -helps evaluate Investigators and assist with selection of study sites to conduct clinical trials -coordinates and conducts GCP, ICH, and VICH -review study records and data for Quality Control -assist with creation of materials and documentation for the study -ensure protocol compliance -timely monitoring of… Show more Clinical Research Associate II monitoring Veterinary Clinical Trials under GCP and VICH -serve as main contact person between clinical study sites and Argenta -helps evaluate Investigators and assist with selection of study sites to conduct clinical trials -coordinates and conducts GCP, ICH, and VICH -review study records and data for Quality Control -assist with creation of materials and documentation for the study -ensure protocol compliance -timely monitoring of electronic data capture data entry systems -assist with study enrollments, enrollment issues/concerns, signed consent forms, and study site personnel listings -monitor investigatory product inventory -travel to study sites to qualify, initiate and close out clinical study sites -train site personnel on protocol and GCP -site recruitment -assist in marketing strategies



AlcheraBio, Part of Argenta

• Clinical Research Associate I

  • Oct 2019 - Dec 2020

  Clinical Research Associate I monitoring Veterinary Clinical Trials under GCP and VICH -serve as main contact person between clinical study sites and AlcheraBio -helps evaluate Investigators and assist with selection of study sites to conduct clinical trials -coordinates and conducts GCP, ICH, and VICH -review study records and data for Quality Control -assist with creation of materials and documentation for the study -ensure protocol compliance -timely monitoring of… Show more Clinical Research Associate I monitoring Veterinary Clinical Trials under GCP and VICH -serve as main contact person between clinical study sites and AlcheraBio -helps evaluate Investigators and assist with selection of study sites to conduct clinical trials -coordinates and conducts GCP, ICH, and VICH -review study records and data for Quality Control -assist with creation of materials and documentation for the study -ensure protocol compliance -timely monitoring of electronic data capture data entry systems -assist with study enrollments, enrollement issues/concerns, signed consent forms, and study site personnel listings -monitor investigatory product inventory -travel to study sites to qualify, initiate and close out clinical study sites -train site personnel on protocol and GCP -site recruitment -assist in marketing strategies

• Associate Clinical Research Monitor

  • Jan 2018 - Oct 2019

  -serve as main contact person between clinical study sites and AlcheraBio -helps evaluate investigators and assist with selection of study sites to conduct clinical trials -coordinates and conducts GCP, ICH, and VICH -review study records and data for Quality Control -assist with creation of materials and documentation for the study -ensure protocol compliance -timely monitoring of electronic data capture data entry systems -assist with study enrollments, enrollement… Show more -serve as main contact person between clinical study sites and AlcheraBio -helps evaluate investigators and assist with selection of study sites to conduct clinical trials -coordinates and conducts GCP, ICH, and VICH -review study records and data for Quality Control -assist with creation of materials and documentation for the study -ensure protocol compliance -timely monitoring of electronic data capture data entry systems -assist with study enrollments, enrollement issues/concerns, signed consent forms, and study site personnel listings -monitor investigatory product inventory -travel to study sites to qualify, initiate and close out clinical study sites -train site personnel on protocol and GCP -site recruitment -assist in marketing strategies



Ethicon, Inc. (through Kelly OCG)

• Scientist I

  • Feb 2017 - Jan 2018

  Somerville, NJ -Serve as surgical coordinator overseeing surgical conduct and coordination of all surgical activities according to protocol requirements at outside CROs -Travel with Study Director and team to various sites to aid in study implementation, model development, design validation, Voice of Customer, and marketing/sales labs -Assist in the development and implementation of new procedures and technologies. -Assist in and provide surgical and histopathology technical support during research… Show more -Serve as surgical coordinator overseeing surgical conduct and coordination of all surgical activities according to protocol requirements at outside CROs -Travel with Study Director and team to various sites to aid in study implementation, model development, design validation, Voice of Customer, and marketing/sales labs -Assist in the development and implementation of new procedures and technologies. -Assist in and provide surgical and histopathology technical support during research, development & evaluation utilizing inanimate and cadaveric models. -Provide veterinary technical support for multi-species surgical technical support at outside CROs -Schedule facility and study activities -Understand and comply with GLP regulations -Review existing SOPs and aid in the development of new SOPs. -Inventory management

• Surgical Research Technician

  • Nov 2015 - Feb 2017

  Somerville, New Jersey Surgical Coordinator providing support in all aspects of animate model development. Responsible for assisting study directors, data collection and recording, surgical assisting, anesthesia monitoring, pre and post surgical care, animal handling and restraint, gross necropsy and histology. Experience with ex-vivo experimentation such as tissue harvesting, trimming, and preparation and fixation techniques. Working knowledge of SOPs, GLP, and GDP practices. Have written, edited and… Show more Surgical Coordinator providing support in all aspects of animate model development. Responsible for assisting study directors, data collection and recording, surgical assisting, anesthesia monitoring, pre and post surgical care, animal handling and restraint, gross necropsy and histology. Experience with ex-vivo experimentation such as tissue harvesting, trimming, and preparation and fixation techniques. Working knowledge of SOPs, GLP, and GDP practices. Have written, edited and reviewed current SOPs as well as reviewed data, surgical, and animal care records for quality control. Expertise in animal handling and restraint, dosing, and observations as well as surgical experience, anesthesia techniques, and knowledge of in-vivo anatomy and physiology.



Raritan Animal Hospital

• Licensed Veterinary Technician/ Veterinary Assistant Supervisor

  • Jan 2002 - Jan 2016

  Edison, New Jersey Licensed Veterinary Technician in charge of all animal care and medical procedures. Veterinary Assistant Supervisor who was responsible in interviewing, hiring, and training all Veterinary Assistant staff. Developed new assistant training manual and conducting quarterly meetings discussing new topics, agendas, and scheduling, Assist in surgical procedures, working knowledge of digital radiology, dental radiology, ultrasound, medication, IV catheter placement, venipuncture, and fluid… Show more Licensed Veterinary Technician in charge of all animal care and medical procedures. Veterinary Assistant Supervisor who was responsible in interviewing, hiring, and training all Veterinary Assistant staff. Developed new assistant training manual and conducting quarterly meetings discussing new topics, agendas, and scheduling, Assist in surgical procedures, working knowledge of digital radiology, dental radiology, ultrasound, medication, IV catheter placement, venipuncture, and fluid therapy. Posses laboratory skills such as CBC, blood chemistry, CBC blood differentials, cytology, urinalysis, fungassays, and collecting aerobic culture samples. Assist veterinarians with appointments Client education Pet insurance liaison Show less