JOB SUMMARY:
The Research Quality Improvement & Compliance Analyst is responsible to assist in the design, development, execution, and oversight of research implementation processes which include the development of policy, assessment of areas of research compliance risk and vulnerability, and provision and implementation of recommendations to ensure appropriate corrective actions in order to ensure adherence with all international, federal, state and local regulations, laws, and policies.
PRIMARY DUTIES
1. Assist in the design, development, and execution of the research implementation processes which include the applying policy and assessing areas of research compliance risk and vulnerability. Assist in the implementation of improvements and corrective actions. Ensure adherence with all international, federal, state and local regulations, laws, policies and guidelines.
2. Assist in providing education and training to researchers and research staff on the application and implementation of federal, state and international regulations, laws, guidelines, University policies and practices, ethical standards, responsible conduct of research and good clinical research practices for human subjects and animals.
3. Gather current research regulatory and ethical requirements for research study information. Discuss findings with researchers and research staff. Assist in identifying and formulating process steps and compliance markers. Assist with advising researchers about ethical standards, human subjects and animal protection issues. Assist with conducting education and training programs for researchers.
4. Prepare basic information to researchers in protocol development, study conduct, regulatory binder preparation, clarification and documentation of study procedures, maintenance of study records, IRB submissions and modifications, conflict of interest, data security, and reporting requirements.
5. Assist in the review for a unit/school internal research review committee.
6. Execute internal quality management processes to ensure compliance with research requirements. Assist in the resolution of regulatory issues as needed.
7. Develop knowledge of federal, state, and local laws as well as University policy to identify changes regarding statutes and rulings that might affect research projects and compliance. Assist in the notification to researchers of changes and devises strategies to successfully implement required updates.
8. Maintain databases to store accurate and comprehensive records of research activities. Maintain attendance records and update/track education and training status in the program database for regulatory purposes. May assist with the maintenance of departmental information ensuring up-to-date faculty CV's, current licensures, lab certifications, lab normal and abnormal values, staff training certifications.
9. Prepare reports to comply with appropriate regulations on research activities to management and other audiences.
Note: The intent of this list of primary duties is to provide a representative summary of the major duties and responsibilities of this job. Incumbents perform other related duties assigned. Specific duties and responsibilities may vary based upon departmental needs.
MINIMUM QUALIFICATIONS:
EDUCATION: Bachelor
EXPERIENCE: One (1) year of experience in clinical and/or laboratory research or related experience involving regulatory compliance issues.
OTHER:
REQUIRED KNOWLEDGE/SKILLS/ABILITIES:
Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently
OTHER:
Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 college credits being equivalent to one year of experience.
CONDITIONS OF EMPLOYMENT:
N/A
