UCSD Layoff from Career Appointment: Apply by 10/21/20 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/02/20. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will remain open until filled.
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 Clinical Research Coordinator 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 Clinical Research Coordinator 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.
The Clinical Research Coordinator 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.
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.
Proven experience working with patients with pulmonary hypertension or similar respiratory diseases either in a clinical or research setting. Knowledge of diagnostic studies used and medications used to treat pulmonary hypertension.
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. Strong experience in clinical trials research including budget negotiations and invoicing 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 te
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.