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Coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, assessment, and maintenance of subjects for randomized clinical trials testing a mindfulness meditation-based intervention for the treatment of chronic pain, opioid misuse, and addiction within UCSD ONEMIND (Optimized Neuroscience-Enhanced Mindfulness Intervention Design) in the Department of Psychiatry
Create informational and recruitment materials and act as a liaison with other UCSD departments, collaborators, and agencies for the purpose of implementation of studies
Plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned team as well as lead, direct, and coordinate operational efforts
Contribute to recruitment and data collection and 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
Perform data acquisition at MRI facilities, strictly adhering to safety protocols and maintaining operator certification under the UCSD Health Center for Functional MRI (CFMRI)
As needed, and with proper training, will also collect ECG and EEG data and process blood and/or tissue samples
Assist PIs with proposals, progress reports and manuscripts
Work closely with federal and state regulatory officials
Requirements
Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science or a related field and/or an equivalent combination of education and work experience
Demonstrated experience in clinical trials research. Strong 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 budgeting and leading study staff, per clinical trial agreement
Strong 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
Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians
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 in conducting searches on the internet
Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions
Demonstrated experience using statistical software applications. Proven knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word
Must meet criteria for eligibility to participate in MRI scanning on high field strength magnets, as determined by the MR facility safety and operator training requirements
Must be eligible for, willing to obtain, and able to maintain independent MRI scanner operator privileges
Nice to have
Possess a Clinical Research Coordinator Certificate or Master's Degree
Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures
Clinical research experience with participants who have substance use disorders, psychiatric disorders, or chronic pain conditions
Knowledge and experience with UCSD IRB, regulatory, human resources, and purchasing functions