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Larissa Kimberly Rugg
UPI: 10755051
811 Long Meadow Drive, Schaumburg IL
H: 312-857-8891 C: 315-269-8641 W: 847-938-4114
larissarugg@gmail.com
EDUCATION
Bachelor of Science in Biology, Syracuse University at Utica College December 2011
Relevant Coursework:
Forensic Biology, Forensic Anthropology, Histology, Biochemistry, Organic Chemistry I and II, Anatomy and Physiology I
and II, Forensic Botany, Forensic Biology, Genetics, Cellular Biology, Forensic Psychology, Animal Physiology, Research
Methods I and II, Statistics, Physics, Calculus
CLINICAL RESEARCH EXPERIENCE
Clinical Systems Support Associate March 7, 2016- present
Pharmaceutical Research and Development
Planet Pharma on assignment to Astellas Pharma Inc.
Managing an application on/off boarding process via excel spreadsheets and SharePoint. Change Control ,
Coordination of all systems set-up using the Integrated System set-up form, Study start-up tracking, Supporting
IMPACT (a clinical data system), Site creation, Reference Data Entry/Data QC. Define application problem by
conferring with clients; evaluating procedures and processes. Develop solution by preparing and evaluating
alternative workflow solutions. Control solution by establishing specifications; coordinating production with
programmers. Validate results by testing programs. Ensure operation by training client personnel; providing support.
Provide reference by writing documentation. Update job knowledge by participating in educational opportunities;
reading professional publications; maintaining personal networks; participating in professional organizations.
Accomplish information systems and organization mission by completing related results as needed.
Clinical Research Assistant October 20, 2014- March 23, 2016
Pharmaceutical Research and Development
AbbVie
Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH
guidelines, and critically reviewing document content to ensure accuracy and completeness in order to authorize
release of investigational product (IP) to study sites. Ensure documents maintained in the file are appropriate and
the content of those documents is accurate, complete and consistent with Abbott SOPs and regulatory
requirements. Ensure required site documentation remains current during the conduct of a study, and providing
safety and relevant study updates to the IRB. Master clinical documentation management and tracking skills,
effective interaction with Abbott professionals, external sites and vendors, Task prioritization and timeline
adherence, Abbott electronic systems and tools (e.g. IMPACT, IVRS/IRT, EDC, eDocs, OSCAR, etc.), and maintenance
of an audit- and archive-ready Trial Master File (TMF).
Clinical Research Specialist April 28, 2014-October 20, 2014
Pharmaceutical Research and Development
AbbVie Contracted through Aerotek
Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH
guidelines. Support clinical team, primarily in tracking, organizing and filing Phase I-IV study documents according to
Federal Regulations and ICH guidelines. Assist Clinical Team members in handling data queries, drug inventories, study
invoice payments, enrollment tracking, and record reconciliation with site documents. Assist the CRAs with organizing
and planning study investigator meetings.
Clinical Research Coordinator October 2012 – March 2013
SUNY Upstate Medical University
Research Foundation Department of Neurology
Project coordination for clinical research trials involving drug development and device implantation for patients with
ALS; institutional review board regulatory correspondence and maintenance; screen, register and enroll patients for
clinical research trials involving drug development and device implantation; schedule appointments for clinical trial
patients; data collection and recording for clinical trials involving drug development and device implantation;
maintenance of clinical research supplies; process clinical trials billing. Coordination of industry and/or investigator
initiated clinical trials involving drug development and device implantation; maintaining subject and other study related
records; correspondence with local and central IRBs including writing applications; continuing reviews; adverse event
reporting; submitting documents to sponsors; maintenance of regulatory files; study meetings, site training, attending
investigator meetings out of state, and all aspects of trial administration.
LABORATORY & HEALTHCARE EXPERIENCE
Medical Case Manager December 2013- April 28, 2014
Medical Healthcare Reform Department
RSA Medical
Naperville, IL
Serves medical clients by conducting medical interviews with clients via phone to obtain information that has been
requested, ensures a professional, efficient, thorough and accurate interview is completed to meet the needs of the
client and RSA. Uses a consultative approach supported by medical knowledge and defined policies and procedures to
uncover and collect additional critical details (calculated, expanded questioning) regarding conditions, treatment,
medication usage, recovery etc. Proactively serves as an advocate to assist the applicant in the collection of vital medical
information by contacting medical care facilities and medical offices, physicians etc. to obtain information required to
fully complete the medical interview. Acts as a courteous, professional medical representative and customer advocate to
obtain necessary information, document collected information efficiently and credibly to ensure a complete and
accurate medical interview is completed and filed with the insurance carrier. Responsible for following defined policies,
procedures and standards for professional conduct, the MCM must perform within Quality standards to ensure
consistent, accurate, professional client engagements. Act in compliance with all HIPAA guidelines and standards of care
in client interactions. Use good judgment, tact and compassion to handle the delicate exchange of personal health
information. Works from a solid medical foundation - able to assess, respond and articulate information related to
medical interviews and processes that support the business' medical transactions.
Laboratory Technician I
Life Sciences Division
SGS U.S. Testing Company INC. April 2013 – October 2013
Lincolnshire, IL
Preparation of medical device samples (dialysis tubing, hemo bags, heart catheter kits, dialysis filters, knee
replacements, hip replacements, skin grafts, gastrointestinal mesh, surgical kits, syringes, needles, IV bags, etc), analysis
of samples by LAL for endotoxin testing, data interpretation and report writing. Instrument maintenance and scheduling
of analysis as required. Report to a Manager in the Microbiology Laboratory. Responsible for conduct of endotoxin
testing performed on pharmaceutical products and medical devices, as well as assisting other Analysts in the completion
of their tasks.
Dr. Sultana Razia’s Medical Assistant July 2012 – October 2012
Hematology/Oncology Department
Slocum-Dickson Medical Group
New Hartford, NY
Worked under the direct supervision of a RN and a licensed physician performing work related duties as required.
Assumed responsibility for various clinical and clerical functions within the office. Scheduled patient appointments,
answered incoming phone calls, consulted with physician and/or nurse practitioner regarding phone messages. Greeted
patients and checked the waiting area for arrivals. Obtained patient vitals, and prepared patients for exams providing a
comfortable environment. Checked on patients while waiting in exam rooms. Recorded BP, TPR, height and weight.
Documented patient care and phone messages in medical records, and requisitioned ancillary services. Cleaned, stocked
and maintained exam rooms, maintained equipment and reported faulty equipment. Changed office schedule if needed,
prepared patient chart, maintained confidentiality of all information regarding patients, maintained good public
relations with other departments, MD’s, patients and families. Assisted physician with procedures such as Bone Marrow
extraction within the office with the exception of procedures involving delivery of medications. Attended OSHA upon
initial employee orientation.
Specimen Processing Specialist
St. Luke's Hospital
Labcorp/Centrex Labs March 2008 – July 2012
Utica, NY
Processed patient specimens collected at St. Luke's or surrounding patient centers. Verify all patient information such as
date of birth, sex, diagnosis, reviewing insurance information, and billing. Maintaining inventory and laboratory supplies
as well as laboratory equipment. Prepare and maintain medical records for tests performed. Order tests to be
performed at doctor's request. Enter diagnosis codes and log specimens as received. Prepare and deliver specimens to
appropriate departments in the lab where testing will be performed. Effectively communicate with doctors, nurses, and
lab staff to efficiently process and complete all testing.
Lab Assistant/Histological Embedding Team
Greensboro Pathology, LLC March 2007 - January 2008
Greensboro, NC
Processed, embedded, and prepared tissue specimens for the microtomy team. Safely handled chemicals, including
formalin and xylene, and carefully followed proper cleaning regiments. Accurately followed and maintained knowledge
of MSDS reports on chemicals in the laboratory. Completed training in fire safety, blood-borne pathogens, and slide
staining and preparation for pathologist's reading. Maintaining inventory and laboratory supplies as well as laboratory
equipment. Received full training as a Lab Assistant, requiring me to perform the duties as a part of the Histological
Embedding Team.
CERTIFICATIONS and TRAINING
AbbVie Corporate Integrity Agreement (CiA) recertification process April 26, 2014
AbbVie Study Management with IMPACT: Study Management Training May 6, 2014
Collaborative Institutional Training Initiative (CITI) Certification for Glaxo Smith Kline October 29, 2012
Columbia Suicide Severity Rating Scale Training for Glaxo Smith Kline December 2012
Dynamometer and Pulmonary Function Test Training December 2012
FDA GMP and GLP Training through SGS April 2013
HIPAA Training through RSA Medical January 2014
HIPAA and GLP Training through Labcorp March 2008,
'09, '10, '11, '12
LABORATORY SKILLS
Experience with the dissection of human cadavers, and I have observed an autopsy. Centrifuge usage and decanting
supernatant fluids, slide staining and smear preparation, electrophoresis, titration, microscopic analysis and
identification of cells, macroscopic and microscopic identification of mycology specimens and bacterial specimens,
experimental data recording, dissection, accurate use of a micropipette, thin layer chromatography, use of a
spectrophotometer, ability to read and identify chemical compounds using carbon¹³ and proton nuclear magnetic
resonance spectroscopy, infrared spectroscopy, agarose gel preparation, and more.
COMPUTER SKILLS
EHR; IMPACT; EDC; IRT (Endpoint, Clinphone);Citrix SoftLab; SPSS; Mirador; LIMS- laboratory information management
system; Microsoft Office; Internet Explorer; Google Chrome; Windows Media Center; MS XP Professional and Win7,
Windows 8, 10; MS Office; Adobe Acrobat, Photoshop; Virus/Spyware/Adware Protection and prevention

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CV Larissa Rugg_23Mar2016

  • 1. Larissa Kimberly Rugg UPI: 10755051 811 Long Meadow Drive, Schaumburg IL H: 312-857-8891 C: 315-269-8641 W: 847-938-4114 larissarugg@gmail.com EDUCATION Bachelor of Science in Biology, Syracuse University at Utica College December 2011 Relevant Coursework: Forensic Biology, Forensic Anthropology, Histology, Biochemistry, Organic Chemistry I and II, Anatomy and Physiology I and II, Forensic Botany, Forensic Biology, Genetics, Cellular Biology, Forensic Psychology, Animal Physiology, Research Methods I and II, Statistics, Physics, Calculus CLINICAL RESEARCH EXPERIENCE Clinical Systems Support Associate March 7, 2016- present Pharmaceutical Research and Development Planet Pharma on assignment to Astellas Pharma Inc. Managing an application on/off boarding process via excel spreadsheets and SharePoint. Change Control , Coordination of all systems set-up using the Integrated System set-up form, Study start-up tracking, Supporting IMPACT (a clinical data system), Site creation, Reference Data Entry/Data QC. Define application problem by conferring with clients; evaluating procedures and processes. Develop solution by preparing and evaluating alternative workflow solutions. Control solution by establishing specifications; coordinating production with programmers. Validate results by testing programs. Ensure operation by training client personnel; providing support. Provide reference by writing documentation. Update job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations. Accomplish information systems and organization mission by completing related results as needed. Clinical Research Assistant October 20, 2014- March 23, 2016 Pharmaceutical Research and Development AbbVie Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines, and critically reviewing document content to ensure accuracy and completeness in order to authorize release of investigational product (IP) to study sites. Ensure documents maintained in the file are appropriate and the content of those documents is accurate, complete and consistent with Abbott SOPs and regulatory requirements. Ensure required site documentation remains current during the conduct of a study, and providing safety and relevant study updates to the IRB. Master clinical documentation management and tracking skills, effective interaction with Abbott professionals, external sites and vendors, Task prioritization and timeline adherence, Abbott electronic systems and tools (e.g. IMPACT, IVRS/IRT, EDC, eDocs, OSCAR, etc.), and maintenance of an audit- and archive-ready Trial Master File (TMF). Clinical Research Specialist April 28, 2014-October 20, 2014 Pharmaceutical Research and Development AbbVie Contracted through Aerotek Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines. Support clinical team, primarily in tracking, organizing and filing Phase I-IV study documents according to
  • 2. Federal Regulations and ICH guidelines. Assist Clinical Team members in handling data queries, drug inventories, study invoice payments, enrollment tracking, and record reconciliation with site documents. Assist the CRAs with organizing and planning study investigator meetings. Clinical Research Coordinator October 2012 – March 2013 SUNY Upstate Medical University Research Foundation Department of Neurology Project coordination for clinical research trials involving drug development and device implantation for patients with ALS; institutional review board regulatory correspondence and maintenance; screen, register and enroll patients for clinical research trials involving drug development and device implantation; schedule appointments for clinical trial patients; data collection and recording for clinical trials involving drug development and device implantation; maintenance of clinical research supplies; process clinical trials billing. Coordination of industry and/or investigator initiated clinical trials involving drug development and device implantation; maintaining subject and other study related records; correspondence with local and central IRBs including writing applications; continuing reviews; adverse event reporting; submitting documents to sponsors; maintenance of regulatory files; study meetings, site training, attending investigator meetings out of state, and all aspects of trial administration. LABORATORY & HEALTHCARE EXPERIENCE Medical Case Manager December 2013- April 28, 2014 Medical Healthcare Reform Department RSA Medical Naperville, IL Serves medical clients by conducting medical interviews with clients via phone to obtain information that has been requested, ensures a professional, efficient, thorough and accurate interview is completed to meet the needs of the client and RSA. Uses a consultative approach supported by medical knowledge and defined policies and procedures to uncover and collect additional critical details (calculated, expanded questioning) regarding conditions, treatment, medication usage, recovery etc. Proactively serves as an advocate to assist the applicant in the collection of vital medical information by contacting medical care facilities and medical offices, physicians etc. to obtain information required to fully complete the medical interview. Acts as a courteous, professional medical representative and customer advocate to obtain necessary information, document collected information efficiently and credibly to ensure a complete and accurate medical interview is completed and filed with the insurance carrier. Responsible for following defined policies, procedures and standards for professional conduct, the MCM must perform within Quality standards to ensure consistent, accurate, professional client engagements. Act in compliance with all HIPAA guidelines and standards of care in client interactions. Use good judgment, tact and compassion to handle the delicate exchange of personal health information. Works from a solid medical foundation - able to assess, respond and articulate information related to medical interviews and processes that support the business' medical transactions. Laboratory Technician I Life Sciences Division SGS U.S. Testing Company INC. April 2013 – October 2013 Lincolnshire, IL Preparation of medical device samples (dialysis tubing, hemo bags, heart catheter kits, dialysis filters, knee replacements, hip replacements, skin grafts, gastrointestinal mesh, surgical kits, syringes, needles, IV bags, etc), analysis of samples by LAL for endotoxin testing, data interpretation and report writing. Instrument maintenance and scheduling of analysis as required. Report to a Manager in the Microbiology Laboratory. Responsible for conduct of endotoxin testing performed on pharmaceutical products and medical devices, as well as assisting other Analysts in the completion of their tasks.
  • 3. Dr. Sultana Razia’s Medical Assistant July 2012 – October 2012 Hematology/Oncology Department Slocum-Dickson Medical Group New Hartford, NY Worked under the direct supervision of a RN and a licensed physician performing work related duties as required. Assumed responsibility for various clinical and clerical functions within the office. Scheduled patient appointments, answered incoming phone calls, consulted with physician and/or nurse practitioner regarding phone messages. Greeted patients and checked the waiting area for arrivals. Obtained patient vitals, and prepared patients for exams providing a comfortable environment. Checked on patients while waiting in exam rooms. Recorded BP, TPR, height and weight. Documented patient care and phone messages in medical records, and requisitioned ancillary services. Cleaned, stocked and maintained exam rooms, maintained equipment and reported faulty equipment. Changed office schedule if needed, prepared patient chart, maintained confidentiality of all information regarding patients, maintained good public relations with other departments, MD’s, patients and families. Assisted physician with procedures such as Bone Marrow extraction within the office with the exception of procedures involving delivery of medications. Attended OSHA upon initial employee orientation. Specimen Processing Specialist St. Luke's Hospital Labcorp/Centrex Labs March 2008 – July 2012 Utica, NY Processed patient specimens collected at St. Luke's or surrounding patient centers. Verify all patient information such as date of birth, sex, diagnosis, reviewing insurance information, and billing. Maintaining inventory and laboratory supplies as well as laboratory equipment. Prepare and maintain medical records for tests performed. Order tests to be performed at doctor's request. Enter diagnosis codes and log specimens as received. Prepare and deliver specimens to appropriate departments in the lab where testing will be performed. Effectively communicate with doctors, nurses, and lab staff to efficiently process and complete all testing. Lab Assistant/Histological Embedding Team Greensboro Pathology, LLC March 2007 - January 2008 Greensboro, NC Processed, embedded, and prepared tissue specimens for the microtomy team. Safely handled chemicals, including formalin and xylene, and carefully followed proper cleaning regiments. Accurately followed and maintained knowledge of MSDS reports on chemicals in the laboratory. Completed training in fire safety, blood-borne pathogens, and slide staining and preparation for pathologist's reading. Maintaining inventory and laboratory supplies as well as laboratory equipment. Received full training as a Lab Assistant, requiring me to perform the duties as a part of the Histological Embedding Team. CERTIFICATIONS and TRAINING AbbVie Corporate Integrity Agreement (CiA) recertification process April 26, 2014 AbbVie Study Management with IMPACT: Study Management Training May 6, 2014 Collaborative Institutional Training Initiative (CITI) Certification for Glaxo Smith Kline October 29, 2012 Columbia Suicide Severity Rating Scale Training for Glaxo Smith Kline December 2012 Dynamometer and Pulmonary Function Test Training December 2012 FDA GMP and GLP Training through SGS April 2013 HIPAA Training through RSA Medical January 2014 HIPAA and GLP Training through Labcorp March 2008, '09, '10, '11, '12 LABORATORY SKILLS
  • 4. Experience with the dissection of human cadavers, and I have observed an autopsy. Centrifuge usage and decanting supernatant fluids, slide staining and smear preparation, electrophoresis, titration, microscopic analysis and identification of cells, macroscopic and microscopic identification of mycology specimens and bacterial specimens, experimental data recording, dissection, accurate use of a micropipette, thin layer chromatography, use of a spectrophotometer, ability to read and identify chemical compounds using carbon¹³ and proton nuclear magnetic resonance spectroscopy, infrared spectroscopy, agarose gel preparation, and more. COMPUTER SKILLS EHR; IMPACT; EDC; IRT (Endpoint, Clinphone);Citrix SoftLab; SPSS; Mirador; LIMS- laboratory information management system; Microsoft Office; Internet Explorer; Google Chrome; Windows Media Center; MS XP Professional and Win7, Windows 8, 10; MS Office; Adobe Acrobat, Photoshop; Virus/Spyware/Adware Protection and prevention