This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 07/02/2020 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 07/13/2020. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Clinical and Translational Research Institute (CTRI) was established to provide education, training and infrastructure for clinical research in the San Diego area that encompasses four hospital systems, two universities and four biomedical research organizations. It has significant support through a Clinical and Translational Science Award funded by the National Center for Advancing Translational Science.
The clinical coordinator core is housed in the Center for Clinical Research, a division of the CTRI. Oversee Clinical Trials Administration and Regulatory compliance, coordination and documentation of specified pharmaceutical clinical trials and protocols. Responsible for development of protocols and execution of procedures. Responsible for ensuring that all procedures comply with regulatory procedures and standard operating procedures. Design case report forms for PI initiated and Sponsor provided protocols. Assume responsibility for multi-site clinical trials for the Clinical and Translational Research Institute and its partners, including Rady Hospital. Responsibilities include the development and maintenance of all study related documents and procedures for the FDA, CRO and Pharmaceutical Company; oversee execution of protocols to be conducted at the site; and coordinate, assign, and evaluate the activities of in-house coordinating staff to ensure FDA Compliance and Good Clinical Practice. This position will require developing, updating and refining of Standard Operating Procedures. Additionally, responsible for study recruitment, including the innovation of screening process to improve patient and clinical trial databases. Responsible for performing protocol defined procedures as required. Independently collect and analyze scientific data for publication, identify and develop new clinical trial protocols, train and monitor research staff, medical students, fellows, hospital nurses assigned to these protocols. Incumbent is required to use Velos, a mandatory clinical trials management system that is used to track all patients enrolled in a clinical trial, track all scheduled visits and individual events performed at each visit and is used for studies that have a conventional care coverage analysis.
Strong theoretical knowledge and/or Bachelor's Degree in a life science and/or an equivalent combination of education and work experience.
Must have current CPR certificate or ability to attain within two months of hire date.
Demonstrated experience in research protocol activation, marketing, outreach, recruitment and maintaining a research study cohort.
Experience performing vital signs.
Demonstrated experience with composing clinical trials reports including HRPP applications, protocol amendments, adverse event reports, close out documents, CRFs.
Experience using clinical trials management software. VELOS experience highly desirable.
Demonstrated ability to plan, organize and implement clinical trials with complex logistics involving various sites and multiple tasks and priorities.
Demonstrated experience in maintaining quality control in clinical trial protocols, including adherence to the protocol requirements and data management.
Analytical and evaluative ability to evaluate clinical trial data and PI/Sponsor needs.
Excellent communication skills.
Ability to read, understand, and learn study procedures from protocols. Ability to problem solve. Strong, demonstrated knowledge of the clinical research setting, protocols, principles, and standards. Excellent planning and organization skills. Ability to work in a changing multiple-demand setting and to prioritize a large volume of work and meet deadlines efficiently and accurately. Ability to work independently.
Demonstrated skill in establishing and maintaining effective relationships with staff of all levels, faculty and health care professionals.
Experience in analyzing research data, extracting pertinent data, analyzing and presenting data effectively.
Experience using clinical laboratory equipment including pipettes, centrifuges, ECG machines. Knowledge of good clinical practice guidelines.
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.