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General Information

Work Location: Los Angeles, USA
Onsite or Remote
Fully Remote
Work Schedule
Monday – Friday, 8:00am - 5:00pm
Posted Date
06/08/2023
Salary Range: $76200 - 158800 Annually
Employment Type
2 - Staff: Career
Duration
Indefinite
Job #
6878

Primary Duties and Responsibilities

The Regulatory Affair Project Manager will oversee, manage and participate in startup research activities as part of the Translational Clinical Research Unit while under the direction of Financial Administrative Officer, Faculty Director, Medical Director, and Research Director (Senior Management) of the Jonsson Comprehensive Cancer Center Clinical Research Unit. In this role, you will be responsible for the oversight of regulatory coordination for clinical research studies. This includes responsibility for regulatory coordination of clinical research studies, preparation, submission and maintenance of regulatory files to fulfill research requirements. Coordinating and reporting on the efforts/timelines of fund management, clinical trials administrative office and coverage analysis. Work with Study Monitors to process, review and collect the appropriate regulatory documents in a timely manner. Must have the ability to work flexible hours and/or overtime to meet study deadlines and requirements. Work may be assigned by Senior Management, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner.

Salary offers are determined based on various factors including, but not limited to, qualifications, experience, and equity. UCLA Health annual salary range for this position is $76,200.00 - $158,800.00.

Job Qualifications

Required:
• Minimum of 3+ years of experience of clinical research coordination 
• 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. 
• Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
• 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 knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
• Knowledge of and 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.

Preferred: 
• Bachelor’s degree


As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.