University of California San Diego
Location
La Jolla, CA | United States
Job description
This is a UC San Diego Internal Recruitment open to UCSD and UCSD Health System Staff Only
UCSD Layoff from Career Appointment : Apply by 02/20/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants : Apply by 02/22/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.
Under general direction of the Principal Investigator (PI) and Sponsored Project Administrator in the Pulmonary, Critical Care & Sleep Medicine Division, the Clinical Research Coordinator will independently perform and oversee the clinical research efforts for a variety of research projects and clinical trials focusing primarily on pulmonary hypertension and related conditions.
Drawing on experience with Industry, National Institutes of Health (NIH), and society sponsored research, the incumbent will monitor study participant compliance, evaluation and quality assurance procedures, oversee the quality of clinical and research data and write annual reports; oversee the regulatory process for site, Institutional Review Board (IRB), research compliance and Food and Drug Administration (FDA) audits, and ensure compliance of Health Insurance Portability and Accountability Act (HIPAA) regulations of patient confidentiality throughout the studies, manage the acquisition, preparation, and distribution of patient financial compensation.
The incumbent will contribute original ideas for developing, improving, and implementing study protocols, offering insight at the regulatory, operational, clinical, and technical levels. Incumbent will oversee the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files.
Incumbent will draft and assist in the drafting of manuscripts as an author or coauthor. Manuscript contributions will include study design, collage/figure design and creation, analysis of manuscript data, and completion and submission of manuscript. The candidate will be responsible for assigned aspects of grant proposal preparation and submission, including technical writing and editing, budget preparation, and aiding in compliance with federal, state and university regulatory requirements for funded research.
Key to this role is the preparation of study protocols, related regulatory documents, and progress reports for submission to the IRB; oversight and management of laboratory operations, such as ordering lab and study supplies, keeping up to date on safety protocols, clinical billing recharges, and IRB approval and maintenance. This includes acting as a liaison for numerous investigators and staff.
Incumbent 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.
Strong theoretical knowledge and/or Bachelor's Degree in a 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 working in a Pulmonary & Critical Care Office or clinical research environment including knowledge of pulmonary medical terminology.
Demonstrated experience working with patients with pulmonary hypertension or similar respiratory diseases either in a clinical or research se
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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