HRPP Regulatory Compliance Analyst

Discover Vanderbilt Health: With eight hospitals and over 180 clinics, we are the region’s largest comprehensive academic health system. Vanderbilt Health has a long tradition of providing world-class care to the people of the Mid-South, living out our mission of moving medicine forward through preeminent programs in patient care, education and research. Here you’ll find a spirit of collaboration and a supportive community where your expertise is valued, your knowledge expanded and your uniqueness celebrated. We are committed to fostering an environment where talented, compassionate people are united in bringing the most advanced care to our neighbors throughout the region.

Organization:

VICTR

Job Summary:

HRPP Regulatory Compliance Analyst

In your pivotal role as a HRPP Regulatory Compliance Analyst, you will ensure continuity and consistency of the research proposal process under occasional guidance. You will also facilitate the protocol process from submission to completion.

This position works normal business hours Monday – Friday and offers the opportunity to work remotely.

BASIC QUALIFICATIONS
• Bachelor's Degree (or equivalent experience) (Required)
• 2 years experience (Required)
• Required to pass the HRPP training and orientation program within 6 months of employment.

About the Department:
The VUMC Human Research Protections Program (HRPP) supports the ethical and responsible conduct of human participants research across the institution. Working in partnership with investigators, study teams, and institutional leadership, the program helps ensure that research involving human participants is conducted in a manner that protects their rights, safety, and well-being. The HRPP oversees and supports all types of human research and promotes compliance with applicable regulations and institutional policy. The HRPP plays a key role in advancing high-quality research that benefits individuals and communities. For more information, please visit Welcome | Human Research Protections Program

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KEY RESPONSIBILITIES

• Prepares, analyzes, reviews, and processes new research proposals, amendments, adverse events, and continuing review applications prior to committee meetings.
• Analyzes proposal submissions for coordination of biosafety and/or radiation review.
• Processes Single IRB submissions.
• Applies HRPP policy and federal regulations to proposed research.
• Prepares for and facilitates committee meetings by creating and pre-reviewing agenda templates and meeting materials, incorporating regulatory education, and documenting discussions.
• Completes and distributes Committee Action Letters and Final Approval Letters.
• Manages Continuing Review notification(s) prior to expiration date of protocol.
• Performs oversight and verification of database entries.
• Routinely initiates and performs quality audits. Assists in conduct of compliance reviews and directed audits. Provides analysis of results and identifies alternatives for resolution of research issues.
• Assists with development and revision of existing policies and procedures as well as development of new policies and procedures.
• Serves as a preceptor to new staff in the onboarding process.
• Prepares and provides training and acts as internal consultant to staff. Provides training for committee members and the research community.
• Serves on focused intradepartmental task forces.
• Contributes ideas and communicates needs relevant to Strategic Plan development.
• Provides customer service to the VUMC research community, assisting with navigation of research regulations, and the IRB submission process.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES

REGULATORY COMPLIANCE (INTERMEDIATE)

- Demonstrates knowledge of the appropriate rules and regulations and apply them in difficult, stressful and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear. Directs others in interpreting rules and regulations on the job and trains others in them.

PROBLEM SOLVING (INTERMEDIATE)

- Uses critical thinking and process improvement i.e. coaches and mentors development of problem statement, describes current state, identifies root causes, creates future state, coaches and mentors development of solutions and action plans with a sustainability plan. Applies appropriate tools to address issues.

QUALITY ASSURANCE (INTERMEDIATE)

- Understands the goal of increasing organizational productivity and individual performance by making the products and services within your work assignments more efficient and more effective.

CUSTOMER SERVICE (INTERMEDIATE)

- A continuing focus on the needs and requirements of customers, anticipating their needs, remaining sensitive to customers while performing services for them, responsive to customer needs.

COMMUNICATION (INTERMEDIATE)

- Clearly, effectively and respectfully communicates to employees or customers.

Our professional administrative functions include critical supporting roles in information technology and informatics, finance, administration, legal and community affairs, human resources, communications and marketing, development, facilities, and many more.

At our growing health system, we support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at Vanderbilt Health for professional growth, appreciation of benefits, and a sense of community and purpose.

Core Accountabilities:

Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.

Core Capabilities :

Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

Position Qualifications:

Responsibilities:

Certifications:

Work Experience:

Relevant Work Experience

Experience Level:

2 years

Education:

Bachelor's

This role offers the opportunity to make a meaningful impact within Vanderbilt Health, supported by a comprehensive benefits package which may include health, disability, retirement and/or wellness offerings to enhance your well-being and professional growth.

Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.