Research Regulatory Affairs Specialist
National Jewish Health/*National Jewish Health - Main Campus/Research Regulatory Affairs
Full Time (40 hours per week)
Work Hours: 8:00 am - 5:00 pm
Req # 12894
The Research Regulatory Affairs Specialist assists in the development and implementation of compliance programs for National Jewish Health. Supports with monitoring business activities for compliance with applicable rules and regulations.
- Provides administravie support to Research Regulatory Affairs, this includes but is not limited to creating correspondence, memos, reports, or other documents to include formatting documents, spelling and punctuating accurately, proofreading and editing. Answers, screens and routes phone calls, takes messages, schedules appointments, and manages calendars. Duplicates documents, processes and distributes mail, sets up and maintains filing systems (both paper and electronic). Is responsible for trouble-shooting office equipment problems.
- Works with the RRA Staff in the implementation, and management of the Quality Improvement Program (QIP) and Post Approval Monitoring (PAM) for NJH research.
- Involved in the implementation and management of policies, procedures, Standard Operating Procedures (SOPs), practices and forms.
- Assists with electronic submissions, to include intake reviews and post approval processing. Responsible for developing forms and templates within the software, ensuring the accurate input of information.
- Assists with communication between committees and researchers, serving as a point of contact and subject matter expert on the regulations that govern the conduct of research.
- Evaluates compliance with applicable regulations and policies, study conduct, organization, record keeping, and documentation. Provides investigators with clear feedback to improve their protocols and understanding of research compliance.
- Monitors NJH research for up to date compliance with applicable federal regulations and guidelines and NJH Policies and Procedures. Oversees uniform application of clinical research systems, policies and procedures across all research areas.
- Performs QIP and PAM initiatives and audits of RRA committees. Conducts random and for cause audits of investigator sites and monitors research process. Assists in preparations for external audits, inspections and assists with reports to regulatory agencies.
- Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health.
- Adaptability: Maintains effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures. Tries to understand changes; approaches change or newness positively; adjusts behavior.
- Attention to Detail: Accomplishes tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time. Sets high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
- Collaboration/Teamwork: Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.
- Initiative: Takes prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive. Responds quickly, takes independent action, and goes above and beyond.
- Managing Work and Time/Project Management: Effectively managing one’s time and resources to ensure that work is completed efficiently. Effectively manages project(s) by appropriately focusing attention on the critical few priorities; effectively creates and executes against project timelines based on priorities, resource availability, and other project requirements (i.e., budget); effectively evaluates planned approaches, determines feasibility, and makes adjustments when needed.
- Peer Relationships: Interacts with others in a constructive, positive, and respectful manner, regardless of individual differences. Assists team members or co-workers in achieving personal goals and completing assignments.
Supervisory or Managerial Responsibility
- Be available to work as scheduled and report to work on time.
- Be willing to accept supervision and work well with others.
- Be well groomed, appropriately for your role and wear ID Badge visibly.
- Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
- Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.
- Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
- Wears appropriate PPE as outlined by the infection control policies and procedures.
- Demonstrates compliance with all state, federal and all other regulatory agency requirements.
Bachelor’s degree required.
Two years of recent and related experience preferred.
Special Training, Certification or Licensure