IBD Asst. Clinical Research Coordinator
University of California – San Diego Medical Centers
San Diego, California
Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT
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This is a UC San Diego Internal Recruitment open to UCSD and UCSD Health System Staff Only UCSD Layoff from Career Appointment: Apply by 03/30/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Special Selection Applicants: Apply by 04/01/21. Eligible Special Selection clients should contact their Disability Counselor for assistance. DESCRIPTION =========== Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing. The IBD Asst. Clinical Research Coordinator will support the clinical research efforts in the Clinical Trials Office of the Division of Gastroenterology, Inflammatory Bowel Disease (IBD). Demonstrates thorough knowledge of International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines. Establishes processes and develops procedures with minimal direction for performing all phases of studies, complying with privacy legislation, regulatory laws and institutional guidelines. Coordinates and manages individual clinical trials in conjunction with the clinical nurse coordinator. Also in conjunction with the nurse coordinator, is responsible for protocol monitoring of individual studies, ensuring protocol compliance, adverse drug reaction reporting, monitoring of patient treatment and toxicities, and maintenance of accurate and complete clinical research files. Assist with human subjects submissions. Develop budgets in conjunction with Clinical Trials Administrative Services (CTAS). Assist PI with regulatory functions pertaining to the study. Provides information and educates study protocol participants and study personnel. Responsible for ensuring study requirements for data collection, storage and retrieval are met. MINIMUM QUALIFICATIONS ====================== * Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor’s degree, or an equivalent combination of education and experience. * Experience performing clinical research duties in a clinical research environment. * Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word. * Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities. * Experience working with FDA policies regulating clinical trials. * Experience in medical assessment and patient interviewing to determine toxicities related to protocol management. * Experience interpreting medical charts, experience in abstracting data from medical records. * Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens. * Experience with clinical trials participant or study subject recruitment. Experience coordinating study startup activities. * Experience providing in-service training to various research personnel on protocols, processes, and procedures. * Knowledge of x-rays, scans, and other diagnostic procedures. * Strong planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately. * Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills. PREFERRED QUALIFICATIONS ======================== * Certification as a Clinical Research Associate or Coordinator. * Experience working with research bulk accounts. * Experience with investigational drug authorization criteria. * Knowledge of Irritable Bowel Disease research and implications. * Knowledge of Gastroenterology medical terminology. SPECIAL CONDITIONS ================== * Employment is subject to a criminal background check and pre-employment physical. * Occasional evenings and weekends may be required.