Research & Development
Innovation in Practice
Operating one of the industry’s largest and most respected research programs, Kaiser Permanente employs nearly 1,800 research experts at 9 specialized centers across the country. With a research budget of $221 million and more than 2,500 studies and clinical trials underway at any given time, this is a place where you can have a profound impact on the future of health.
Research Project Manager - Program Manager (IRB / FDA Submissions)Location: Pasadena, CA Job Number: 897257 Date posted: 09/03/2020
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Manages research support staff for clinical trials. Accountable for complex planning to coordinate support to large physician network. Implements high visible projects. Works independently in accordance with established objectives.
- Develops department plans which identify key issues, problems, approaches, performance metrics and resources required.
- Assists in development of different tools (e.g. tracking forms, regulatory review forms, etc.).
- Monitors progress of study submissions and eligibility reviews activities (e.g. IRB applications, protocol eligibility, recruitment, etc.) and ensures that reports are submitted in a timely manner.
- Contributes to high level discussions and acts as liason, problem solver, and facilitator between management, Sponsor, Contract Research Organizations (CRO), and research site.
- Prepares progress reports independently and/ or collaboratively.
- Actively participates in the training of new team members and/or clinical staff.
- Ensures that all staff requirements and certifications are complete and current.
- Identifies staff training needs and resources to address needs.
- Develops and executes training plans.
- Works with Sponsors/monitors during study start up and when they conduct monitoring visits.
- Adheres to compliance and privacy/confidentiality requirements and standards.
- Adheres to GCP and compliance regulations for clinical trials.
- Oversees IRB submissions and reviews processes to ensure they remain current.
- Makes recommendations for process improvements and/or enhancements.
- Implements quality control and quality assurance measures when needed.
- Acquires and maintains knowledge of KP systems and databases.
- Makes decisions for day-to-day operations of projects including the resolution of technical problems and questions from project staff.
- Collaborates with Clinical Trials Operations Manager and medical center staff to facilitate Program operations.
- Negotiates and manages time commitments and resources.
- Interfaces with IRB and drafts IRB new applications, amendments, continuing reviews, etc as necessary.
- Supervises and manages the day-to-day activities of research support staff including evaluating performance and conducting regular and annual performance meetings.
- Mentors, develops and trains staff.
- Conducts hiring and disciplinary actions in partnership with the Clinical Trains Operations Manager.
- Provides consultation to investigators and clinic coordinators on staff-related concerns.
- May provide leadership and direction to multidisciplinary project teams.
- Serves as a member and may provide leadership on department or study-related committees.
- Prepares and oversees project budgets.
- Seeks to develop cost effective ways to manage own resources.
- Manages all aspects of clinical trial research studies in assigned medical center coverage area(s).
• Minimum five (5) experience in a clinical research setting.
• Minimum three (3) years of research project management experience.
• Bachelor's degree.
License, Certification, Registration
• Ability and/or experience in developing and implementing research tools.
• Ability and/or experience developing and presenting professional reports and presentations to senior-level audiences.
• Abilitiy and/or experience managing budgets, preferably research project budgets.
• Direct personnel management experience.
• Must be able to work in a Labor/Management Partnership environment.
- Excellent communication abilites highly preferred.
- Previous experience with IRB and FDA submissions highly preferred.
- Master's degree, preferably in public health, healthcare administration, epidemiology, or related field.
- Experience leading, building and developing research programs preferred.
- Bilingual status preferred.
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.
Learn About Research & Development Careers
Careers in Research & Development
Recognized worldwide for their scientific expertise, our researchers collect data on topics including cardiovascular disease, diabetes, mental health, and drug safety — just to name a few.
In addition to studies centered at these facilities, our physicians and researchers conduct clinical trials of new drugs, medical devices, and other therapies through several organized centers and independently at single sites. Put together, Kaiser Permanente's research centers and scientists comprise one of the largest and most comprehensive nonacademic research programs in the United States.
As a member of this team, you'll engage in meaningful work that has the power to affect outcomes and improve global health. Focused on areas like public-sector health services, epidemiology, and behavioral and clinical research, the work you do will ultimately allow us to improve the cost effectiveness and quality of the care we deliver — all while saving lives.
Connect with a member of the Kaiser Permanente team at an upcoming career or professional event. We look forward to seeing you!