Jessica L S.
Contract Cra @Duke Clinical Research Institute
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WORK HISTORY
Contract Cra @Duke Clinical Research Institute
Cincinnati, OH, US
Perform site selection, initiation, monitoring and close-out visits in accordance withy contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• 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 applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.• 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.• Act as a mentor for new clinical staff.• May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes.
EDUCATION
Grand Valley State University
Bachelors of Science, Behavioral Science
Western Michigan University
some Masters experience, Masters of Social Work
ABOUT JESSICA L S.
I currently serve as a Contract CRA, serving sites throughout the life cycle of a clinical research study. My experience includes being a Senior Clinical Research Associate (CRA) 3 at IQVIA (formerly QuintilesIMS) and a Lead CRA at Medpace. As a multiple-study CRA and a Lead CRA for over 10 years, it is imperative that I am organized and able to multi-task. Leading global clinical research teams of up to 25 individuals, I have experience leading global CRA teams. I also identify training needs, and create and implement training tools to ensure that team members are in the best position to be successful. While serving as the main resource for teams of up to 35 clinical researchers, I worked in conjunction with the Clinical Operations management team to facilitate creative solutions when unforeseen issues arose. This role also included traveling domestically to up to 38 clinical research sites. During my tenure at the Muscular Dystrophy Association (MDA), I managed volunteer recruitment and training, engaged in community outreach and education, and led fundraising efforts. As the Summer Camp Director for the MDA summer camp, I was responsible for the programming of all overnight summer camp activities, as well as ensuring the safety of 30 children living with Muscular Dystrophy. As the Health Care Services Coordinator, I was responsible for organizing multiple philanthropic events, all of which exceeded their fundraising goals, while staying within a set budget for expenses. I have a passion for empowering individuals find the strength they possess within themselves through yoga, meditation, and community.
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