Lead Clinical Research Coordinator - 133852

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.

The Lead Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-IV research studies in Neuroimmunology as well as lead, direct, and coordinator operational efforts. They will act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. They will additionally: 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. Manuscript contributions will include study design, collage/figure design and creation, analysis of manuscript data, and completion and submission of manuscript. They will be responsible for assigned aspects of grant proposal preparation and submission, including technical writing and editing, budget preparation, and aiding in compliance with federal, state and university regulatory requirements for funded research.

agencies for the purpose of implementation of studies. They will additionally: 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, budgets, progress reports and manuscripts. Manuscript contributions will include study design, collage/figure design and creation, analysis of manuscript data, and completion and submission of manuscript. They will be responsible for assigned aspects of grant proposal preparation and submission, including technical writing and editing, budget preparation, and aiding in compliance with federal, state and university regulatory requirements for funded research.

Drawing on experience with Industry, National Institutes of Health (NIH), and society sponsored research, the incumbent will determine interest of groups in trial participation, assess ability to execute protocol safely and properly, independently monitor study participant compliance, evaluation and quality assurance procedures, oversee the quality of clinical and research data and write annual reports; oversee the regulatory process for site, Institutional Review Board (IRB), research compliance and Food and Drug Administration (FDA) audits, and ensure compliance of Health Insurance Portability and Accountability Act (HIPAA) regulations of patient confidentiality throughout the studies, manage the acquisition, preparation, and distribution of patient financial compensation.

The incumbent will work with leadership on developing, improving, and implementing study protocols, offering insight at the regulatory, operational, clinical, and technical levels. Incumbent will oversee the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports based on the local and study guidelines, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Other duties assigned as needed.

• Advanced theoretical knowledge and Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

• Advanced knowledge of experimental protocols, data gathering, protocol design and evaluation.

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.

• Advanced knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

• Strong experience completing clinical trials case report forms via hard copy and online.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Working knowledge of medical and scientific terminology.

• Proven ability to problem solve and resolve conflict.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience conducting searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

• Ability to work on clinical trials involving stem cell research.

• Clinical Trial certification preferred.

• Experience with Kuali Research and Kuali IRB.

• Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• At least 10-15 years of demonstrated experience working in clinical research environment as a clinical research coordinator.

• At least 5 years of demonstrated experience working with patients with neurodegenerative diseases either in a clinical or research setting. Knowledge of diagnostic studies used, and medications used to treat neurodegenerative diseases.

• Employment is subject to a criminal background check and pre-employment physical.Occasional evenings and weekends may be required.

• Must be willing to travel to occasional meetings and work weekends and evenings as needed.

• Must be willing to work with human blood and biohazardous materials.