Provides support, coordination and leadership for studies that involves industry-sponsored Phase I, II, III, and IV clinical trials, government-funded clinical research, and investigator-initiated clinical research. Ensures smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure. Prepares documentation for submission for review by the Institutional Review Board (IRB), recruits and screens study participants, coordinates their clinical treatment and follow-up care, and helps facilitate their continued participation; abstracts data from medical records and other sources; collects, submits and maintains study data and regulatory documents; develops and ensures compliance with study protocols; acts as liaison between study sponsor, contract research organization (if applicable), site PI, and patients. Review IRB approved consents for appropriate signatures. Assists PI in study feasibility assessments. Collaborate with PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budget costs. Knowledge of Good Clinical Practices and ALCOA. Attention to detail; strong interpersonal skills; excellent, effective verbal and written communications skills to coordinate with subjects, team members, other departments and outside agencies. The ability to multi-task in a fast-paced environment and a good team player. Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines. Willing to travel to Investigator meetings, if required. Help oversees assistant clinical research coordinator and students.
The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.
Salary: Hourly $25.86 - $29.92 Total Hours: 8-5, M-F Career Position. Willingness to work flexible hours, including occasional evenings and/or weekends as needed. Access to transportation to deliver/pick up important documents at UC Irvine Campus and UCI Medical Center in Orange. Availability to travel to attend investigator meetings for new clinical trials. Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts. Please attach your resume.
Since 1965, the University of California, Irvine has combined the strengths of a major research university with the bounty of an incomparable Southern California location. UCI's unyielding commitment to rigorous academics, cutting-edge research, and leadership and character development makes the campus a driving force for innovation and discovery that serves our local, national and global communities.