Job Information
UCLA Health Project Manager in Los Angeles, California
Description
The Department of Emergency Medicine is currently seeking a Project Manager with responsibilities encompassing various aspects of regulatory compliance and project management within the General Study Team. Duties include analyzing highly complex regulatory issues and devising solutions, independently organizing and executing regulatory project plans, contributing to quality improvement initiatives and SOP development, and facilitating investigator-initiated trials including FDA submission and reporting. The role involves managing a high-volume, complex regulatory portfolio and serving as a liaison between study sponsors, regulatory agencies, investigators, and various institutional bodies to ensure protocol and regulatory compliance. Additionally, responsibilities include timely response to monitoring visits and requests, managing systems for reporting critical matters, participating in quality control activities and audits, and keeping abreast of regulatory policies. The role extends to study activation and pre-study preparation, entailing detailed protocol review, obtaining study approvals, communicating with stakeholders, and maintaining regulatory and financial documents. During study maintenance, tasks involve reviewing protocol amendments, preparing regulatory binders, submitting required reports to regulatory agencies, and coordinating monitoring visits. Upon study closeout, responsibilities include managing closeout visits, ensuring proper documentation submission, notifying relevant teams, and overseeing long-term record storage in compliance with regulations.
Annul range: $78,800-$175,000Qualifications
Required:
Bachelor's degree required, Master's degree preferred
Minimum of 4+ years of experience in a clinical regulatory role
Expert knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
In depth experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.
Demonstrated analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
Demonstrated experience with FDA processes and procedures.
Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.
Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.
Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.
Demonstrated analytical skills to address problems of high complexity.
Ability to think creatively to develop solutions affecting the full team.
UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person’s unique achievements and experiences to further set us apart.