Victoria Nuanes
Clinical Research Supervisor at University of Colorado Anschutz Medical Campus- Claim this Profile
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English -
Topline Score
Bio
Credentials
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Good Clinical Practices
Collaborative Institutional Training Initiative (CITI Program)Mar, 2018- Oct, 2024 -
Certified Clinical Research Coordinator (CCRC)
Association of Clinical Research ProfessionalsOct, 2019- Oct, 2024
Experience
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University of Colorado Anschutz Medical Campus
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United States
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Higher Education
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700 & Above Employee
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Clinical Research Supervisor
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Jul 2021 - Present
•Arranges orientation and provides training, supervision and leadership to the clinical research staff. •Assists clinical research staff with technical issues, problem solving and intervention when appropriate; delegates responsibility for elements of the conduct of selected clinical trials. •Acts as an interdepartmental liaison with UCH clinic staff (i.e. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology). •Plans and directs investigator and coordinator meetings including but not limited to pre-study qualification visits, initial orientations, study audits, and closeout visits. •Makes recommendations regarding clinical research personnel issues, including performance evaluations, counseling, and disciplinary actions with guidance from Clinical Research Manager.•Work with finance team members to resolve discrepancies and to review account balances on a regular basis.•Participate in external audits and internal process improvement strategies to promote consistent best practices.•Assures compliance with all protocol details which includes ensuring the capture of all data points requested on a protocol-specific basis and ensuring that tests and procedures required by clinical protocols are performed and documented
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Clinical Research Coordinator
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Mar 2018 - Dec 2021
As a CRC on the Melanoma team at the University of Colorado Cancer Center, I am responsible for meeting study-specific goals and timelines while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as needed. Additionally, I am responsible for coordinating study subject appointments throughout the study, as well as scheduling, coordinating, and preparing for monitoring visits and audits. Lastly, I am responsible for data entry and resolution, study subject advocacy; and possible management of studies at the local level. I communicate effectively with study subjects, investigators, and other team members while demonstrating outstanding customer service skills and accepting responsibility in maintaining respectful relationships. I perform all of the above tasks in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines.
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Pharmatech
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Associate Project Manager
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Mar 2017 - Mar 2018
I am responsible for providing oversight and administrative support to multiple clinical projects. To ensure that all project timelines are met, I assist in the preparation of accurate and timely regulatory submissions of core project documents, while coordinating with IRBs, sponsors, sites and other vendors. I maintain the Trial Master File, coordinate weekly project meetings, including agendas and minutes, prepare reports, and am in regular communication with clients. I also support contract negotiations and other site activation tasks.
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Project Assistant
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Jul 2015 - Mar 2017
Responsible for providing regulatory and administrative support to the assigned Pharmatech Project and Site Management Teams. Provide support for project administrative tasks, mass mailings, document management, subject recruitment campaigns, travel arrangement, meeting coordination and special projects. Responsible for preparing accurate, timely regulatory submissions of core project documents for clinical research studies and for monitoring and submitting changes of any core project documents to the appropriate persons, the Institutional Review Boards (IRBs) and the pharmaceutical sponsor companies or CROs.
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Education
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2010 - 2014
University of Colorado Boulder
Bachelor of Arts, Molecular, Cellular, and Developmental Biology
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