Clinical Research Coordinator
University of California San Francisco 60 reviews - San Francisco, CA

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Dr. Hendren’s clinical research program within the Division of Child and Adolescent Psychiatry involves multiple clinical studies in the area of autism and other neurodevelopmental disorders prevalent in children, adolescents and young adults.

For this particular position, the clinical research coordinator will, with supervision, work in a collaborative research project between UCSF and Oak Hill School (OHS). OHS is a school setting for students with autism and related developmental differences. The position will involve regulatory (start-up) work including developing and submitting new study applications to IRB including writing consent forms and creating CRFs for compliance to CHR. The coordinator will conduct research projects at OHS reviewing school records and asking parents for additional diagnostic and medical evaluations and reports and then performing and recording this review. The coordinator will also review the OHS outcome data base to determine what records are kept and in what format. The coordinator will then work with the database team to develop an outcomes database for OHS and begin entering data. In addition, the coordinator will work with the team to develop a comprehensive assessment protocol and characterization of treatment.

As a backup and in the future, the coordinator will oversee the administration of multiple clinical studies. Coordinating is predominantly for FDA regulated drug studies, including industry sponsored Phase I, II, III, and IV clinical trials, governmental-funded clinical research, and investigator-initiated foundation. s/he responsibilities are to: prepare documentation for submission for review by the Committee on Human Research (CHR); recruit and screen study participants, coordinate their clinical treatment and follow-up care, and help facilitate their continued participation; collect, submit and maintain study data and regulatory documents; ensure compliance with study protocols; and participate in the planning, development, and budgeting for clinical studies.

Required Qualifications
• BA/BS in a related science and one or more years of recent, directly related work experience following degree completion, utilizing the techniques or methods required by the position; or an equivalent combination of education and experience;
• Experience coordinating sponsored clinical trials or experience working with children and families affected by autism (at least one of these is required, both preferred)
• Knowledge of the research process required to execute research protocols
• Knowledge of ethical principles and federal and state regulations governing the participation of human subjects in biomedical research
• Knowledge of IRB/CHR requirements, FDA regulations, and Good Clinical Practices to carry out safe and appropriate research with human subjects
• Knowledge of various types of word-processing, spreadsheet, database, and presentation software as well as use of internet-based data gathering systems and clinical trial management systems
• The ability to work both independently and as part of a multidisciplinary team
• Excellent interpersonal and oral communication skills to effectively work with other research and administrative support staff
• Ability to determine workload priorities in an appropriate way to accomplish tasks or goals, and anticipate and solve potential problems
• Ability to prioritize and meet deadlines in a dependable and timely fashion
• Ability to work well and communication effectively with child and adolescent research subjects and their parents
• Proficiency to effectively use personal computer and software such as Word, Excel, and various industry oriented Electronic Data Capture programs
• Good oral and written communication skills to effectively work with physicians, patients and families, clinical staff, and other health care professionals
• Organizational skills and attention to detail in maintaining accurate, retrievable records
• Accurate and precise writing, printing, and typing skills

Note: Fingerprinting and background check required.

Physical Demands: requires sitting; standing; walking; squatting; bending; waist twisting; kneeling; crawling; climbing stairs; reaching up to shoulder height; reaching above shoulder level; carrying/lifting 20 pounds; gripping/grasping, fine/gross finger manipulation; repetitive movements of upper and lower extremities; loud noises; chemical agents; latex, verbal communication; use protective equipment.

Preferred Qualifications
• Knowledge of the research process required to execute research protocols
• Prior UC experience
• Experience administering and scoring educational/psychological evaluation with children
• Certification of research reliability on the Autism Diagnostic Observation Schedule (ADOS)
• Certification of research reliability on the Autism Diagnosis Interview – Revised (ADI-R)
• Experience assisting with phlebotomy procedures/ sample collection for children with autism
• Experience recruiting patients for autism trials and ability to execute recruitment goals
• Working knowledge of behavioral science, psychology and research design

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