Manager, Research Project Management

• Jul 2022 - Present

Senior Associate, Research Project Manager

• Jan 2020 - Aug 2022

Project Manager for The Parkinson's Progression Markers Initiative 2.0 (PPMI). PPMI 2.0 is a landmark observational clinical study to comprehensively evaluate cohorts of significant interest using advanced imaging, biologic sampling and clinical and behavioral assessments to identify biomarkers of Parkinson's disease progression. The mission of PPMI is to identify one or more biomarkers of Parkinson’s disease progression. The discovery of a biomarker is a critical step in the development of new and better treatments for PD. This study is being sponsored by The Michael J. Fox Foundation for Parkinson's Research. https://www.ppmi-info.org/

Senior Clinical Research Associate

• Feb 2019 - Jan 2020

Contracted partner with Amgen Pharmaceuticals as part of IQVIA’s Functional Service Partnership.  Perform initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.  Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas including oncology.  Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.  Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to the applicable regulations.  Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.  Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.  Recommend processes to Clinical Management that optimize the use of project resources.  Provide mentoring and support to less experienced members of the project team and advice.

Senior Clinical Research Associate

• Mar 2018 - Feb 2019

Clinical Research Associate II

• Jan 2016 - Mar 2018

• Attend sponsor calls and internal team calls to stay informed of current study issues.• Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.• Conduct site visits to determine protocol and regulatory compliance, and prepared required documentation.• Develop collaborative relationships with investigative sites, client company personnel and study vendors.• Review case report forms for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements.• Performs drug accountability and reports serious adverse events promptly.• Provides site staff training on computer systems, protocol and study manuals, as applicable for study.

Clinical Research Site Monitor

• Jun 2012 - Dec 2015

-Clinical Research Monitor for Juvenile Mycophenolate Phase II Clinical Trial in Batten Disease (JUMP).-Manage mulitple investigational sites across the country and ensure sites maintain requisite regulatory and study specific documentation and adherence to the protocol. -Ongoing supervision of investigative sites to assess compliance with protocol, sponsor, GCP and regulatory requirements in order to ensure the safety of subjects and accuracy of data.-Conduct pre-study, site initiation, interim monitoring, and study closeout visits and complete associated reporting requirements in accordance with SOPs

Clinical Research Coordinator

• Jan 2009 - Jun 2012

Sports Medicine Division of Orthopaedics-In charge of implementing, conducting and monitoring over 20 clinical research studies of the Orthopaedic (Sports Medicine Division) Department in both inpatient and outpatient settings.-Coordinate protocol-specific patient enrollment and recruitment activities such as scheduling protocol specific appointments with physicians, administering questionnaires, phlebotomy, sample collection, and EKG’s. -Also involved in protocol development, recruiting, screening and enrolling participants, obtaining participant informed consent, scheduling tests and procedures, collection of clinical research data, ensuring accuracy of documentation, dispensing study medications, managing the use of investigational devices, and maintaining databases -Assist in development of study protocols, budgets, and Institution Review Board applications.-Negotiations of budgets and protocols with large Orthopaedic companies including ArthroCare, Arthrex, Johnson and Johnson, Kensey Nash, and Pfizer.

Clinical Research Coordinator- Oncology

• Jan 2008 - Jan 2009

-Coordinate protocol-specific patient enrollment and recruitment activities such as scheduling protocol specific appointments with physicians, administering questionnaires, exercise testing, Vo2 Max testing, etc.-Also involved in protocol development, recruiting, screening and enrolling participants, obtaining participant informed consent, scheduling tests and procedures, collection of clinical research data, ensuring accuracy of documentation, dispensing study medications, managing the use of investigational devices, and maintaining databases Assist in development of study protocols, budgets, and Institution Review Board applications.

Certified Spinning Instructor

• Jan 2008 - Jun 2015

Cycling Instructor at the Pittsford RAC

Program Director/Fitness Instructor

• Jun 2005 - Jan 2008

Manager of all the trainers in the club and help them provide the highest level of service to all the membersTested members on their exercise abilities to help develop a proper exercise program for each individualInvolved in formulating ideas with the partners of the company in order to improve the Rochester Atheltic Club and the programming department.Set up members on exercise programs that may best suit their abilities to enhance their health and well beingInstruct on proper form when using the exercise machines for safety and physical ability of membersTrack member's blood pressure, heart rate, percent body fat, measurements, etc to show benefits and progression of a proper diet and exercise program

Floor Trainer

• Jan 2003 - Jun 2005

Set up members on exercise programs that may best suit their abilities to enhance their health and well being Instruct on proper form when using the exercise machines for safety and physical ability of members Track member's blood pressure, heart rate, percent body fat, measurements, etc to show benefits and progression of a proper diet and exercise program Set up members on exercise programs that may best suit their abilities to enhance their health and well being Instruct on proper form when using the exercise machines for safety and physical ability of members Track member's blood pressure, heart rate, percent body fat, measurements, etc to show benefits and progression of a proper diet and exercise program