Regulatory Specialist II, Clinical Trials
Kaiser Permanente · Pasadena, CA · 2 wk ago
LegalFull-time
Responsibilities
- Pursues effective relationships with others by sharing resources, information, and knowledge with coworkers and members. Listens to, addresses, and seeks performance feedback.
- Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship.
- Supports the preparation and maintenance of study-related regulatory documents (e.g., protocol and consent forms, brochures, events documentation, compassionate use application).
- Supports regulatory quality assurance activities for the department; assists in the preparation for internal and external inspections and audits.
- Maintains and/or supports the development of policies and procedures for new guidance/regulatory standards.
- Completes standard investigational product applications for approval.
Requirements
- Bachelor's degree in Science, Public Health, Health Care Administration, or a directly related field OR Minimum three (3) years of experience in clinical research or a directly related field.
- A Certifed Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA).
- Basic Life Support (BLS) Certification from the American Heart Association.
Qualifications
- Attention to Detail
- Business Knowledge
- Communication
- Critical Thinking
- Cross-Group Collaboration
- Decision Making
- Dependability
- Diversity, Equity, and Inclusion Support
- Drives Results
- Facilitation Skills
- Health Care Industry
- Influencing Others
- Integrity
- Learning Agility
- Organizational Savvy
- Problem Solving
- Short- and Long-term Learning & Recall
- Teamwork
- Topic-Specific Communication
- Regulatory Agencies
- Trade and Regulatory Compliance
- Accountability
- Adaptability
- Autonomy
- Business Relationship Management
- Compliance
- Data Quality
- Innovative Mindset
- Laboratory Equipment
- Laboratory Procedures
- Managing Diverse Relationships
- Organizational Skills
- Research Ethics
- Stakeholder Management
Skills
- Navigating the Hiring Process
- Supporting the Preparation and Maintenance of Study-Related Regulatory Documents
- Supporting Regulatory Quality Assurance Activities
- Maintaining and/or Supporting the Development of Policies and Procedures
- Completing Standard Investigational Product Applications
Benefits
(Not specified)
Pay
(Not specified)
Schedule
(Not specified)