San Francisco Bay Area
Clinical Operations expert, TMF, Site engagement liaison. IP and Vendor Management
Responsibilities including managing multiple vendors, their budgets, supporting sites with their questions on protocol on a global study for Amyotrophic Lateral Sclerosis (ALS). Participate in weekly meetings with the CRO, and individual vendors. Helped to plan strategic outlook of the study.
Marquette University Alumni Association Purpose Develop a passionate community of Marquette alumni in support of the university and each other. National Board Purpose The MUAA National Board of Directors assembles to offer counsel and support to Marquette University on issues and initiatives with an alumni focus. National Board members share a passion for Marquette, serve as active and engaged alumni role models, and empower and motivate fellow alumni to connect in innovative and meaningful ways with the university. Guiding Principles Continuous learning Inclusivity of all people Finding God in all things Lifetime alumni relationships Excellence, faith, leadership, service What Jesuit Values you mean to me? Care of the whole person. As a result, experiences in the world, through either service projects or the practical application of classroom knowledge, are a key part of education. Ignatius Loyola said that if individuals follow their desire, they will find God. In order to find that desire, students need a broad basis of knowledge from which to begin seeking. Another reason that Jesuit education emphasizes the liberal arts is so that students can find God in all things. And finally, Jesuits believe that students should be able to converse on a range of topics. Faith. Mission. Service. Jesuits are networkers, which is why they care that students can converse on a range of topics, Jesuit education prepares men and women to go out into the world. Anticipatory joy. Jesuit education should inspire students to want more and to seek to live with enthusiasm.
Currently Managing large late phase trial with Sponsor.
• I perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • I provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. I communicate with the Sponsor and Site with regular monitoring visit reports. • I am able administer protocol and related study training to my assigned sites and help establish regular lines of communication with sites to manage ongoing project expectations and issues as they arise. • I evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. I escalate quality issues to Clinical Team Lead (CTL) and/or Clinical Team Manager (CTM) and help them support the team, study and management goals. • I 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 and other required study documentation. • I provide assistance to less experienced clinical staff and help them in their mentorship of the industry.