Clinical Trials Specialist - Nephrology & Hypertension - Vanderbilt University Medical Center
Nashville, TN
About the Job
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:
Nephrology
Job Summary:
Responsible for the timely preparation, planning and quality control of regulatory documents required for human subjects research under occasional guidance. Coordinates review by Institutional Review Board of research proposals/protocols.
Department Summary:
The Division of Nephrology and Hypertension at Vanderbilt University Medical Center (VUMC) has a long and notable history of studying the pathophysiology of, and developing potential therapies for, the prevention and treatment of kidney disease.
Comprised of more than 70 innovative, internationally recognized basic and clinical researchers and active clinicians working in state-of-the-art facilities, our division’s contributions are validated through high-impact publications, strong federal and non-federal grant funding, and a robust clinical program that provides cutting-edge, comprehensive care across the spectrum of kidney disease.
.
KEY RESPONSIBILITIES
• Coordinate protocol and patient consent form process
• Compile and analyze protocol information necessary to write IRB proposals and patient consent forms
• Formulate, design, and revise research proposal forms which are to be completed by research investigators who intend to do research involving human subjects; serve as a resource to these investigators and others who are engaged in research and/or undergoing audits.
• Write consent forms, conferring with PI and/or sponsor on language required. Ensure compliance with federal/IRB regulations
• Review proposals for completeness of preparation and presentation of adequate and appropriately related information
• Communicate and coordinate with research investigators, monitors, IRB, and sponsors on requests for additional information and/or supportive documentation.
• Compose and submit Investigational New Drug Applications to the FDA for drugs needing FDA approval. Inform FDA of all revisions to the study and obtain IRB approval of revisions.
• Supervise clerical support staff to ensure that records and files are properly maintained and that the appropriate documentation is obtained when required
• Maintain database to track protocols, NCI registration, amendment renewals, new submissions, approvals, INDs, outside safety reports, adverse event forms and other data necessary to ensure compliance with regulatory guidelines.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
TECHNICAL CAPABILITIES
• Research Administration (Intermediate): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.
• Medical Records Management (Intermediate): Knowledge of how and where to store and maintain basic records associated with job assignments.
• Laboratory Practices (Intermediate): Demonstrates mastery of laboratory practices in practical applications of a difficult nature. Possesses sufficient knowledge, training, and experience to be capable of successfully delivering products and services using laboratory practices without requiring support and instruction from others. Able to train and educate by setting the example, giving technical instruction, providing leadership, and generally raising the level of performance of others while on the job.
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 :
1 year
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
Organization:
Nephrology
Job Summary:
Responsible for the timely preparation, planning and quality control of regulatory documents required for human subjects research under occasional guidance. Coordinates review by Institutional Review Board of research proposals/protocols.
Department Summary:
The Division of Nephrology and Hypertension at Vanderbilt University Medical Center (VUMC) has a long and notable history of studying the pathophysiology of, and developing potential therapies for, the prevention and treatment of kidney disease.
Comprised of more than 70 innovative, internationally recognized basic and clinical researchers and active clinicians working in state-of-the-art facilities, our division’s contributions are validated through high-impact publications, strong federal and non-federal grant funding, and a robust clinical program that provides cutting-edge, comprehensive care across the spectrum of kidney disease.
.
KEY RESPONSIBILITIES
• Coordinate protocol and patient consent form process
• Compile and analyze protocol information necessary to write IRB proposals and patient consent forms
• Formulate, design, and revise research proposal forms which are to be completed by research investigators who intend to do research involving human subjects; serve as a resource to these investigators and others who are engaged in research and/or undergoing audits.
• Write consent forms, conferring with PI and/or sponsor on language required. Ensure compliance with federal/IRB regulations
• Review proposals for completeness of preparation and presentation of adequate and appropriately related information
• Communicate and coordinate with research investigators, monitors, IRB, and sponsors on requests for additional information and/or supportive documentation.
• Compose and submit Investigational New Drug Applications to the FDA for drugs needing FDA approval. Inform FDA of all revisions to the study and obtain IRB approval of revisions.
• Supervise clerical support staff to ensure that records and files are properly maintained and that the appropriate documentation is obtained when required
• Maintain database to track protocols, NCI registration, amendment renewals, new submissions, approvals, INDs, outside safety reports, adverse event forms and other data necessary to ensure compliance with regulatory guidelines.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
TECHNICAL CAPABILITIES
• Research Administration (Intermediate): Knowledgeable on all phases in the lifecycle of a sponsored research project. Well versed in and able to assist researchers in reducing compliance risks and assisting in routine and specialized processes.
• Medical Records Management (Intermediate): Knowledge of how and where to store and maintain basic records associated with job assignments.
• Laboratory Practices (Intermediate): Demonstrates mastery of laboratory practices in practical applications of a difficult nature. Possesses sufficient knowledge, training, and experience to be capable of successfully delivering products and services using laboratory practices without requiring support and instruction from others. Able to train and educate by setting the example, giving technical instruction, providing leadership, and generally raising the level of performance of others while on the job.
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 :
1 year
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
Source : Vanderbilt University Medical Center