Research - Laboratory/Non-Laboratory, Staff/Administrative
UCSD Layoff from Career Appointment: Apply by 3/14/19 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 3/26/19. 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 and Sponsored Project Administrator in the Pulmonary, Critical Care & Sleep Medicine Division, the Research Coordinator will independently perform and oversee the clinical research efforts for a variety of research projects and clinical trials focusing primarily on asthma, including severe asthma and related conditions.
Drawing on experience with Industry, 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, IRB, research compliance and FDA audits, and ensure compliance of 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. The Research Coordinator 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.
This position will draft 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.
Theoretical knowledge of biology, immunology, microbiology as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.
Experience with interpretation and understanding of research protocols in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
Four years of professional experience working in a clinical research setting with knowledge of protocols, principles and standards.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Demonstrated knowledge of IRB and Human Subjects Research requirements, to include the informed consent and Patient's Bill of Rights.
Demonstrated experience interpreting medical charts, experience in abstracting data from medical records.
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.
Good interpersonal skills, including excellent written and verbal communication skills; ability to with a diverse group of people to include physicians, patients and their families.
Demonstrated experience using database, word processing and spreadsheet applications.
Demonstrated knowledge of FDA policies regulating clinical trials.
Demonstrated experience working in a Pulmonary & Critical Care Office or clinical research environment including knowledge of pulmonary medical terminology.
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.