**Discover Vanderbilt University Medical Center:** Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of diverse individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and where your diversity of culture, thinking, learning, and leading is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.

**Organization:**

VICC- Clinical Trials 90

**Job Summary:**

JOB SUMMARY

Develop and coordinate mechanisms to assure compliance with human subject protection guidelines. Coordinate regulatory, data safety evaluation, and protocol development functions for on-site and multiple sites/affiliates. Provide oversight and education to staff involved in research studies. Audit investigator-initiated protocols and data and present findings to regulatory committees. Assist with study feasibility and budget development.

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KEY RESPONSIBILITIES

- Act as liaison of research activities between investigators, agencies, sponsoring companies, regulatory committees and other participants.

- Oversees the development of protocols, the overall clinical plan, draft protocols, and coordinates the protocol review and approval process with various committees and staff.

- Supervise staff, monitor data, and assign corrective measures for adherence to protocol and regulatory compliance.

- Perform ongoing monitoring and evaluation of studies to assure compliance with federal and institutional regulations

- Develop and implement auditing programs, policies, procedures, documentation and systems in accordance with Federal, State and University mandates.

- Assist in development of research designs, amendments, and evaluations and offers direction in implementation for collection of accurate data evaluation and analysis

- Provides advice, guidance, and problem resolution to PI on protocol design/development and data collective mechanisms.

- Conducts data analysis and provide written research analysis for project components on a regular bases.

- Coordinate protocol submission to the Scientific Review Committee, Radiation Safety Committee, Biosafety Committee, and IRB

- Original proposals are created that meet institutional and FDA regulations

- New research proposals are prepared and processed according to regulations

- Consent forms, amendments, continuing review applications, FDA, IND applications, SAE analysis and reports are prepared and processed according to regulations

- Obtain input from local site's IRB representative to assure consideration of local context issues in different demographic regions as applicable

- Develop and provide training and staff development on regulatory requirements and protocol design

- Develop and deliver training on research protocols to ensure regulatory, and University compliance

- Provide training to physicians, nurses, professors, teachers, data collectors, regulatory coordinators, and technicians and other staff involved in research studies in an understandable manner

- Educational needs are identified based on audits and other information; develop and deliver training as needed

- Provide instruction on the interpretation of test results, and observations

- Implement data safety monitoring mechanisms ensuring regulatory standards are met and coordinate reporting to Data Safety Monitoring Committee while assisting with implementation of corrective measures based on findings of audit of studies.

- Organizes and performs random, for-cause, and regulatory committee-requested audits of research studies as appropriate to ensure compliance with applicable regulations and guidelines

- Analyze data and prepare audit reports and summaries, findings are presented to the Committee(s)

- Ensure databases to track human subject research are implemented and maintained

- Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest standards possible. This includes training with staff development for on-site and off-site personnel as required

- Maintain a current knowledge of Federal, State, and University laws, regulations, guidelines governing human subject research

- Represents human subject compliance programs on various groups and committees as appropriate

- Conducts site visits (travel required)

- Prestudy site visits are conducted as required

- Evaluative reports are prepared

- Site monitoring visits are conducted and followed-up to resolve identified problems

- Files, records, case report forms, and source documents are reviewed for completeness, accuracy, and compliance; identifies deficiencies and discrepancies, and remedial training is provided as needed

TECHNICAL CAPABILITIES

**Our Academic Enterprise** is one of the nation's longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.

World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.

Aligning with Vanderbilt Health's Strategic Directions , the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.

**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 :**

5 years

**Education :**

Bachelor's

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled