Lead Clinical Research Coordinator - 133852

$40 - $52/Yr

University of California System - Not Specified, CA

Full-time - Mid Level

Not Specified, CA

Educational Services

About the position

The Department of Neurosciences is a large department within the UCSD School of Medicine. The Department's mission is to create the synergies and define the ideas and programs that will allow us to transform the way our neurosciences community discovers, teaches and cares. We strive to conduct cutting-edge science and research and train the next generation of neurologists and researchers by fostering education at all levels and integrating the latest scientific and medical advances into the curriculum. The Neuroimmunology Research Program pursues translational and clinical studies to advance understanding and improve the treatment of disorders such as multiple sclerosis, neuromyelitis optica, optic neuritis, and other central nervous system autoimmune diseases. From biomarker and genetic studies to clinical trials, the program offers exciting opportunities to participate in patient-oriented research. Under direction of the Neuroimmunology Program Director, the Lead Research Coordinator will independently coordinate and will be accountable for the overall administration and outcome of multiple clinical studies, requiring advanced-level knowledge and skills, involving human subjects that are being conducted in the Neuroimmunology division. They will provide leadership to lower-level clinical research coordinators, clinical research coordinator assistants and/or other support personnel. Key to this role is managing infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation, working with leadership to ensure proper execution.

Responsibilities

• Plan, develop and implement start-up procedures for multiple phase I-IV research studies in Neuroimmunology.
• Act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies.
• Assure compliance with state and federal regulatory guidelines.
• Oversee the quality of the medical and clinical research data.
• Provide direction and guidance to investigators.
• Provide education and information to the general public concerning the ongoing clinical trials.
• Assist PIs with proposals, progress reports and manuscripts.
• Contribute to manuscript design, analysis of manuscript data, and submission.
• Responsible for assigned aspects of grant proposal preparation and submission.
• Determine interest of groups in trial participation and assess ability to execute protocol safely.
• Independently monitor study participant compliance and quality assurance procedures.
• Oversee the regulatory process for site, IRB, research compliance and FDA audits.
• Manage the acquisition, preparation, and distribution of patient financial compensation.
• Develop, improve, and implement study protocols.

Requirements

• Advanced theoretical knowledge and Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field.
• Advanced knowledge of experimental protocols, data gathering, protocol design and evaluation.
• Demonstrated experience in research protocol start-up procedures, including study feasibility and IRB processes.
• Strong experience in clinical trials research including budget negotiations and invoicing.
• Advanced knowledge of investigational protocols.
• Demonstrated experience performing clinical research duties in a clinical research environment.
• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.
• Strong experience completing clinical trials case report forms.
• Proven ability to find creative and innovative solutions.
• Ability to discern items that can be handled independently and those requiring supervisor attention.
• Working knowledge of medical and scientific terminology.
• Proven ability to problem solve and resolve conflict.
• Excellent ability to organize/prioritize workload effectively.
• Excellent interpersonal, written and verbal communication skills.
• Computer proficiency, including working knowledge of word processing and spreadsheet software.
• Demonstrated administrative experience and skill to coordinate complex activities.
• Ability to work on clinical trials involving stem cell research.

Nice-to-haves

• Clinical Trial certification preferred.
• Experience with Kuali Research and Kuali IRB.
• Knowledge of cost accounting as applied to University and Medical Center functions.
• At least 10-15 years of demonstrated experience working in clinical research environment.
• At least 5 years of demonstrated experience working with patients with neurodegenerative diseases.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401k
• Paid holidays
• Paid time off
• Flexible scheduling