Regulatory Project Manager
3 weeks ago
The UCLA CORE Kidney Health Program is seeking an experienced RegulatoryProject Manager to oversee all regulatory aspects of clinical trials, clinical programs,our patient and community outreach program, education and training, and assistwith administrative tasks.
You will be responsible for the oversight ofregulatory coordination for clinical research studies. This includesresponsibility for regulatory coordination of clinical research studies,preparation, submission and maintenance of regulatory files to fulfill researchrequirements. Coordinating and reporting on the efforts/timelines of fundmanagement, clinical trials administrative office and coverageanalysis. You will work with study monitors to process, review and collectthe appropriate regulatory documents in a timely manner. The idealcandidate will be able to work flexible hours and/or overtime to meet studydeadlines and requirements.Work may be assigned by Senior Management, andassignments may be changed on an as-needed basis in order to ensure thatstudies and patient care needs are handled appropriately and in a timelymanner.
Salary range:
$ $ Monthly
QualificationsRequired:
- Minimum of five years clinical research experience, with in-depth knowledge of clinical oncology.
- Working knowledge of good clinical practices for clinical research.
- Working knowledge in patient electronic medical system.
- Working knowledge in working with Velos or similar system.
- 4 or more years of experience in regulatory processes in clinical research.
- At least a year of experience with UCLA IRB and/or other IRB.
- Working knowledge of clinical research management systems.
- Demonstrated knowledge of "good clinical practices" for clinical research as defined by the FDA.
- 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.
- Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings.
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