University of California San Diego
Location
La Jolla, CA | United States
Job description
UCSD Layoff from Career Appointment : Apply by 2/28/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
/& Special Selection Applicants : Apply by 3/11/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Division of Vascular and Endovascular Surgery within the Department of Surgery at the University of California: San Diego, School of Medicine has a diverse clinical research portfolio that includes investigational device and drug studies, medical management studies, aswell as post-approval clinical trials. With over ten industry or government-funded clinical trials and six Vascular Surgeon investigators, the missions of research, education, and patient care are intertwined, and are integral to the goals of the department. As a leader in researchand patient care, the UC San Diego Department of Surgery is committed to providing the latest in expert and compassionate treatment, performing leading-edge research, and training the next generation of top surgeons and scientists.
Under supervision, the incumbent assists various PI's with research endeavors, coordinates and implements experimental protocols in the Division of Vascular Surgery. Coordinates and monitors clinical trials, recruits and screens subjects, initiates and manages all internal documentation for clinical trials. Incumbent is involved in the acquisition, processing, and identification of pertinent research data, according to protocol, to include identification of abnormal lab/test data. Assists in orientation of patients/families to research studies. Incumbent will assist with FDA reports for physician sponsored study as well as source document creation. Knowledge and experience of IRB submission and Human Subjects protocols and guidelines to accurately complete all necessary components of IRB process. Computer knowledge required for Word, Access and Excel. Must be capable of entering data into computer database and maintaining database.
Reporting directly toResponsible 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.
Theoretical knowledge of microbiology, biology, and physiology.
Experience with research protocol in order to screen patients for eligibility, initiate treatment plan, and orient participating physicians.
Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Ability to use statistical software applications. Knowledge of database, word processing and spreadsheet applications.
Knowledge of x-rays, scans, and other diagnostic procedures.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
Excellent 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.
Ability to work independently and take orders from a number of individuals.
Demonstrated knowledge of ICH/GCP, FDA and HIPAA regulations.
Demonstrated ability to exercise independent judgment and initiative when making decisions regarding various patient, research, administrative and laboratory issues.
Employment is subject to a criminal background check and pre-employment physical.
Must be willing to work flexible hours.
Must have access to reliable transportation.
Must be willing to travel to various offices and clinics, as needed for research projects.
Pay Transparency Act
Annual Full Pay Range: $64,812 - $104,275 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $31.04 - $49.94
Factors in determining the appropriate compensation for a role include experienc
About University of California San Diego
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.
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