Research - Laboratory/Non-Laboratory, Staff/Administrative
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The Movement Disorder Center (MDC), directed by Irene Litvan, MD, was recently created to bring together faculty and staff who specialize in movement disorders, such as Parkinson's disease and related disorders, to work together as a multidisciplinary and comprehensive group to provide the best possible care for patients. Movement disorders are neurological conditions that affect the speed, control, quality and ease of movement.
The UC San Diego Movement Disorder Center is dedicated to providing the best diagnostic, therapeutic, palliative and supportive care to patients with movement disorders. The MDC is conducting clinical trials and is collaborating with investigators both within the UC System and outside the System. Our main objective is to improve the quality of life for our patients and their families and caregivers, while searching for significant ways to advance knowledge of these disorders through a multidisciplinary clinical and research team.
Under supervision, the Clinical Researcher is responsible for independently executing clinical trials activities including 1) participate in the planning, development and implementation of clinical research projects/studies related to Parkinson's disease, atypical Parkinson's disorders, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, Lewy body disease, dementia and other related disorders, 2) provide coordination, testing, guidance and develop protocols in the execution of clinical research, 3) monitor clinical trials, study related activities and provide recruitment support and, 4) oversee human subjects and regulatory affairs (Institutional, State, and Federal) for the movement disorders team. Researcher will act as a liaison with UCSD departments, clinical research organizations (CRO), industry sponsors/contacts and community clinics/agencies.
Theoretical knowledge of medical and pharmaceutical terminology and concepts, and/or biological science, as typically attained by a Bachelor's Degree in pharmacy, biology, hematology, or social sciences, sufficient to prepare, review and understand the contents of medical research protocols and amendments.
Working knowledge of FDA regulations, OPRP, HRPP policies and procedures, and HIPAA. Familiarity with the code of federal regulations (CFRs), Good Clinical Practice (GCP) guidelines and other regulations for the conduct of clinical research.
Experience working with clinical trials research activities, regulatory compliance, guidelines related to informed consent, ethical conduct, and protection of human subjects. Ability to interpret and comprehending complex clinical research protocols, activities and guidelines.
Demonstrated ability to read, understand, and learn study procedures from protocols. Strong problem-solving and decision-making skills.
Demonstrated ability to create or modify Informed Consent documents that comply with HRPP, FDA and other governing agencies.
Ability to abstract information from protocol and investigators brochures to create a stand-alone Research Plan requiring summarizing large quantities of data into concise and condensed applications of approximately 20 pages.
Experience researching information and ability to develop responsive, creative solutions to problems. Ability to analyze data to arrive at valid conclusions, recommendations and plans of actions. Detail oriented, logical and methodological approach to problem solving.
Expertise with personal computers and software programs (including Word, Excel, Power Point). Ability to organize office and develop procedures; maintain and/or develop complex paper and electronic record management filing systems.
Strong ability to write policies, business correspondence, reports and procedure manuals, experience with editing and/or proofreading documents, fast and accurate typing skills; excellent grammatical and proofreading skills.
Ability to research, gather, evaluate, and organize information to produce clear and concise protocol reports using various resources and to perform tasks accurately and quickly, disseminate information effectively whether in report form or via presentation.
Familiarity with cooperative group agencies and trials including experience preparing and submitting variety of forms related to research protocols in compliance with federal policies and other a
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