Clinical Research Regulatory Specialist – Hybrid in Nashville TN

The Research Regulatory Analyst will act as a liaison to the IRB and assist with coordinating the approval processes and regulatory components of research protocols from study start-up to close-out, such that the integrity and quality of the clinical/translational research is maintained, and the research is conducted in accordance with all regulatory policies.

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Key Responsibilities:

• Independently collects, reviews, organizes, assembles, and maintains regulatory documents/binders (paper and electronic) for assigned clinical trials, assuring the research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.

• Independently prepares, reviews, and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional and departmental policies and federal regulations while maintaining timelines for studies from start-up to close-out.

• Proficient with OnCore, Veeva, and project management tools. With occasional guidance, initiates and performs quality control (QC) audits of regulatory documents from OnCore and Veeva. Generates QC Report summarizing the findings.

• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges as evident by monitor/auditor follow-up letters. Assist with building relationships with internal/external stakeholders (i.e., monitors, auditors, and sponsors) by fostering a culture of respect and practicing active communication.

• Demonstrates knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations.

• Supports team working relationships within assigned departments between all levels of personnel by fostering a culture of respect, communication, and ownership.

• The responsibilities listed are a general overview of the position, and additional duties may be assigned.

Technical Capabilities:

• Communication (Intermediate): Clearly, effectively, and respectfully communicate with employees or customers, including external and internal stakeholders i.e., monitors, auditors, and sponsors.

• 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.

• Project Coordination (Intermediate): Performs project tracking and reporting relative to task completion dates, dependency effects, problem anticipation, schedule conflicts, and assignment to appropriate staff for resolution. Assumes responsibility [as appropriate] for resolving issues and seeing work through to successful completion.

• 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.

• Regulatory Compliance (Intermediate): Demonstrates knowledge of the appropriate rules and regulations and applies them in difficult, stressful, and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear.

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.

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

4 years

Education :

Bachelor's (Required)

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.