Research - Laboratory/Non-Laboratory, Staff/Administrative
UCSD Layoff from Career Appointment: Apply by 07/19/2021 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 07/29/2021. 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 supervision from Principal Investigator (PI) and Supervisor in the Pulmonary, Critical Care & Sleep Medicine Division, the Research Coordinator supports the clinical research efforts for a variety of research projects and clinical trials focusing primarily on pulmonary disorders including asthma and related conditions. Responsible for independently coordinating and managing research studies, to include protocol management, screening for patient eligibility, consenting subjects, data collection and entry, patient follow-up, query resolution, and database management. The Research Coordinator will assist in 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. Assist the regulatory department with human subjects submissions, renewals, and safety reports. Provide direct assistance in reviewing, developing and verifying university research account statements, professional fee statements, budget and invoicing.
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.
Theoretical knowledge in biology, immunology, 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.
Demonstrated knowledge of FDA policies regulating clinical trials.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
Demonstrated 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 with interpretation and understanding of research protocols in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
Experience maintaining files and keeping records.
Demonstrated knowledge of IRB and Human Subjects Research requirements, to include the informed consent and Patient's Bill of Rights.
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.
Excellent interpersonal skills, including excellent written and verbal communication skills; ability to with a diverse group of people to include physicians, patients and their families.
Ability to work independently. Ability to maintain confidentiality.
Experience completing clinical trials case report forms via hard copy and online.
Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.
Demonstrated experience using database, word processing and spreadsheet applications.
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.