A detail-oriented, conscientious self-starter, who is able to prioritize and accomplish multiple complex tasks related to clinical research. My 20 years of experience in clinical research has allowed me to develop expertise spanning the full spectrum of clinical research related to clinical and translational trials, including interventional clinical vaccine and therapeutic trials and large epidemiological and observational cohort studies. My skillsets include the ability to recruit in both inpatient and outpatient settings, manage large datasets with great attention to detail and flexibility. I am particularly proud of the work I helped to accomplish with the UR Vaccine and Treatment Evaluation Unit (UR VTEU), an NIH funded research group who led the University of Rochester COVID19 pandemic response including participating in several pivotal trials (ACTI-ACTIII COVID Therapeutic Trials, AzstraZeneca Phase 3 Clinical Trial, Momivax COVID Observational Study, Mix and Match Vaccine Trial.)

EDUCATION

University of Rochester, Rochester, NY 02/2006

Good Clinical Practice Certificate, University of Rochester

University of Rochester, Rochester, NY 02/2006

Human Subject Protection Program Certificate, University of Rochester

University of Rochester, Rochester, NY 10/2019

Point of Care Urine Pregnancy Certificate, University of Rochester

University of Rochester, Rochester, NY

Phlebotomy Certificate, University of Rochester 08/2008

BOCES 2 Center for Workforce Development 09/2000

Network Technician Certificate (285 hours)

Bryant & Stratton College, Rochester, NY 06/1984

Associates Degree in Occupational Studies, Computer Programming

EXPERIENCE

University of Rochester Medical Center, Rochester, NY 1/2018 - 12/2023

Infectious Diseases Research Clinic, UR Vaccine and Treatment Evaluation Unit

Human Subjects Research Coordinator II

•Served as the lead coordinator for several clinical trials, epidemiology and observational studies under the direction of the Principal Investigators (Dr. Branche, Dr. Falsey, Dr. Walsh).

•Performed assessment to determine the feasibility of implementing study protocols with the investigators and sponsors including review of the protocol requirements.

•Developed and completed regulatory submissions both initial, amendments as well asl annual continuing review reports to Internal Review Boards (IRBs) and other research agencies.

•Identified and developed a recruitment plan and the necessary recruitment material; maintained and evaluated the recruitment plan to ensure that all study goals were met with the appropriate accrual levels.

•Develop and oversee regular auditing/quality assurance processes for active studies, ensuring compliance for data entry and reporting requirements, Good Clinical Practice and safety principles.

•Provide professional direction within the project including training of research staff.

•Attended weekly team meetings. Attended Site Selection Visits, Site Initiation Visits, and Sponsor Monitor visits.

•Assessed study subjects and perform study procedures including reviewing patient medical records, eligibility criteria, medical history and medications, collection of vitals and collection of various clinical samples (nasal swabs, nasal aspirate, sputum, urine specimen and blood draw collection).

•Train subjects in how to operate diaries and specimens.

Organized research inventory supplies and charts for each individual protocol; participated in source document development and compiling study summary data.

Performed database management and populated data from various electronic data capture systems, resolved queries for clinical trials.

Participated with the start-up and close-out of clinical research studies.

Maintained a working knowledge of the area(s) of expertise by reviewing the research of literature and abstracts, attending pertinent meetings and seminars.

University of Rochester Medical Center, Rochester, NY 5/2008 - 12/2017

Department of Allergy, Immunology, Rheumatology

Health Project Coordinator I

•Coordinated administrative details required to conduct research studies: distribute, receive explain study information, protocols, consent forms, schedule subject visits, recruitment, subject reimbursement, copy, fax, scan, update and maintain regulatory binders, source documents, case report forms, study requisitions, maintain subject enrollment logs, recruitment materials.

•Submitted research applications, continuing reviews, protocols, informed consent forms, recruitment materials, and case report forms to Research Subjects Review Board (RSRB).

•Followed documentation of dispensing and returning clinical drug and maintain a drug accountability log.

•Utilized the University of Rochester Epic System to view patient medical records to identify a potential study subject, which met the eligibility criteria according to the study protocol.

•Ensured that all of the research team members followed the approved protocols and maintained communication. The principal investigator oversaw all of the training of research team members, and I was responsible for maintaining the training and delegation log. I have assisted the principal investigator with adverse events.

•Participated with the start-up and close-out of clinical research studies, research studies signoffs, amendments of protocols and consent forms, along with maintaining and updating regulatory documentation.

•Liaised between the sponsor monitor and the principal investigator, maintaining a close relationship and communication, responded to data queries and emails, scheduled sponsor visits, submitting to the sponsor monitor study approval letters, and amended consent forms.

•Maintained Good Clinical Practice and standards with research studies.

•Performed database management and populated data from various electronic data capture systems, resolved queries for clinical trials.

•Extracted data from research electronic data capturing system that has been used in abstracts, science papers, and posters created for ACR Meeting for Dr. Christopher Ritchlin. My name has been mentioned in several research papers created by Dr. Christopher Ritchlin for Psoriatic subjects.

•Annually attended the IPART Psoriatic Study Science Meetings in Canada with the principal investigator, Dr. Ritchlin.

University of Rochester Medical Center, Rochester, NY 2/2006 - 3/2007

Department of Public Health Sciences

Information Analyst

• Supported Smoker’s Health Project, including screening, interview, training, and follow-up communication. Backup for department coordinator and secretary.

• Created, maintained, and updated files in Teleform (SPSS), MS Access, Med Cap, and Palm Pilot; setup and terminated user accounts; extracted data to create financial reports.

• Supervised clerical and college intern staff completed weekly time sheets.

TECHNICAL SKILLS

Microsoft Office Suite (Word, Excel, PowerPoint, Access, Outlook, Teams), REDCap. Experience with several database management and electronic data capture systems including Medidata Rave, Emmes, Trial Master, Study Hub, FireCrest, IQVIA, RedCap, Epic System, IRT System, Mediro System, Advarra, Longboat.

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