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Clinical Research Coordinator

  • Anywhere

Company :
University of California – San Diego Medical Centers

Location :
San Diego, California

Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT

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Description :
This position is a limited position with the possibility of extension/career conversion. Special Selection Applicants: Apply by 05/27/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance. DESCRIPTION =========== Under general supervision of the Principal Investigator, the incumbent coordinates clinical trial activities for the Division of Nephrology-Hypertension. Responsible for initiating, developing, implementing, coordinating, and managing through to completion all protocols, clinical trials, and grants. Coordinates protocol screening, enrollment, scheduling and study management. Responsible for coordination of clinical, laboratory and data activities to ensure compliance with protocols. Responsible for detailed data collection, chart abstraction, completion of case report forms, and coordinating data entry and quality assurance activities. Coordinates and manages clinical trials. Provides all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring toxicities, and maintenance of accurate and complete clinical research files. Assists with Human Subjects submissions, correspondence, and FDA related communications. Clinical Research Coordinator will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as lead, direct, and coordinator operational efforts. 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. Independently create original documents and policies for assigned disease teams. Work closely with federal and state regulatory officials. MINIMUM QUALIFICATIONS ====================== * Strong theoretical knowledge and/or Bachelor’s Degree in social science or basic science such as Biology, Microbiology 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. * Experience in research protocol start-up procedures, including; study feasibility, study activation and IRB processes, and qualification procedures. Experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement. * Thorough knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation). * Proven 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. Proven ability to problem solve and resolve conflict. * Strong knowledge of investigational protocols especially with pediatric oncology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation). * Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians. * 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. * Working knowledge of medical and scientific terminology. * Excellent interpersonal, written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with variety of personalities of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. 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. * Extensive administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions. PREFERRED QUALIFICATIONS ======================== * Bilingual (English/Spanish) with ability to read, write, and explain medical procedures in both languages. * Possess a Clinical Research Coordinator Certificate, or Master’s Degree. * Experience in operation and management of radiology and/or nephrology outpatient clinical trials or studies. * Knowledge of cost accounting as applied to both University and Medical Center functions. * Knowledge of medical billing and collections guidelines and procedures. * Knowledge of UCSD Medical Center, JCAHO, and Title XXII hospital licensing regulations. * Knowledge of and ability to communicate and ensure compliance of current UCSD Medical Center and Outpatient Services policies and procedures. * Knowledge about the standard pre-test or pre-procedure instructions which patients should receive. SPECIAL CONDITIONS ================== * Employment is subject to a criminal background check and pre-employment physical. * Occasional evenings and weekends may be required. * Must assume 24-hour on-call responsibilities during study periods if necessary, and be willing to travel occasionally to sites participating in clinical trials.