Public Administration Analyst - Clinical Research

Regulatory Project Manager

Location: Hybrid. On campus (911 Broxton Ave, 3rd Floor LA, CA 90024) and work from home flexibility

Hours: 8:00 am to 5:00 pm (1 hour break)

Duration: 28 week contract

Job Responsibilities:

The Clinical Trial Research Program is seeking an experienced Regulatory Project Manager to oversee, manage, and participate in startup research activities and be responsible for the oversight of regulatory coordination for Clinical Research studies.

This includes being responsible 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.

You will work with study monitors to process, review and collect the appropriate regulatory documents in a timely manner.

Ideal candidate must have 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.

Qualifications:

Working knowledge of good clinical practices for Clinical Research.

Demonstrated organizational skills to efficiently and effectively provide data management/monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner.

Demonstrated ability to prioritize workload to meet demands of PI's, Sponsor and FDA.

Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc.

Demonstrated interpersonal skills to work with patients, their families/guardians, physicians, administrators, work colleagues, representatives from sponsors and other to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.

Ability to understand that work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner. Notify direct supervisor of any conflicts in demand on time or priorities.

Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings