The Research Regulatory Specialist (RRS) position oversees the daily regulatory activities for research studies and coordinates and performs administrative research support services. The primary focus of the RRS will be the achieving and maintaining compliance with all internal, external and federal policies and regulations that apply to the conduct of human subject at National Jewish Health.
1. Prepares study documents for submission to the IRB, sponsor or other regulatory authority and corresponds appropriately with these bodies.
2. Coordinates and performs study specific regulatory processes across multiple studies of different therapeutic areas.
3. Provides regulatory guidance, direction and support to all members of the research team at National Jewish Health.
4. Performs a variety of administrative research tasks in support of the study startup team.
5. Ensures regulatory compliance with all internal, external, federal and state policies, procedures and regulations.
1. 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.
2. Adaptability: Maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
3. Attention to Detail: Accomplishing 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. Setting 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.
4. 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.
5. Decision Making: Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
Supervisory or Managerial Responsibility
1. Be available to work as scheduled and report to work on time.
2. Be willing to accept supervision and work well with others.
3. Be well groomed, appropriately for your role and wear ID Badge visibly.
4. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
5. Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.
6. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
7. Wears appropriate PPE as outlined by the infection control policies and procedures.
8. Demonstrates compliance with all state, federal and all other regulatory agency requirements.
Bachelor’s degree required.
A minimum of 2 years relevant regulatory clinical research experience required.
Special Training, Certification or Licensure