Associate Clinical Research Data Specialist, Pediatric Hematology - 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:
Pediatric Hematology
Job Summary:
JOB SUMMARY
Monitors the data functions and the conduct of research protocols with some guidance. Ensures the integrity and quality of clinical research is maintained.
.
KEY RESPONSIBILITIES
Follows policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research.
Implement policies, procedures, and regulations to know when a patient can/cannot be enrolled on a study and to report protocol non-compliance, adverse events, and serious adverse events.
Implementation, coordination, management and reporting of clinical/translational research operations.
Follow protocols and procedures to submit, review, and seek approval of protocol and protocol related documents. Must be able to review protocols and assist in the development of source documentation to capture data time points needed to obtain objectives of the protocol; train internal and external research staff on protocol and trial expectations as needed
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.
Will work with internal and external research staff on protocol expectations, reporting guidelines, elevate issues to PI of trial, FDA, and other governing bodies as needed to ensure human subjects protection.
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.)
Engages in a minimum of 10 hours of continuous, job-related educational activities annually. Actively seeks new learning opportunities, seeing learning as a part of work.
Key Function #4: Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.)
Specific Examples: Engages in a minimum of 10 hours of continuous, job-related educational activities annually. Actively seeks new learning opportunities, seeing learning as a part of work.
TECHNICAL CAPABILITIES
• Database Knowledge (Novice): Knowledge and understanding of a database and how data is organized so that its contents can easily be accessed, managed, and updated.
• Quality Assurance (Novice): 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 (Novice): 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 (Novice): 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.
• Data Analysis (Novice): The ability to analyze data in an accurate manner.
• Data Entry (Novice): The ability to transcribe information from the original source into an electronic system according to written and verbal instructions efficiently and accurately.
• Project Management (Novice): Planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives.
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: Delivers job responsibilities that impact own job area/team with some guidance. Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement. Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements. Team Interaction: Individually contributes to project/ work teams.
Core Capabilities :
Supporting Colleagues: - Develops Self and Others: Continuously improves own skills by identifying development opportunities.- Builds and Maintains Relationships: Seeks to understand colleagues priorities, working styles and develops relationships across areas. - Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner. Delivering Excellent Services: - Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service. - Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner. - Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support. Ensuring High Quality: - Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards.- Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond. - Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department. Managing Resources Effectively :- Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service. - Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources. - Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error. Fostering Innovation: - Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.- Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action. - Adapts to Change: Embraces changes by keeping an open mind to changing plans and incorporates change instructions into own area of work.
Position Qualifications:
Responsibilities:
Certifications :
Work Experience :
Relevant Work Experience
Experience Level :
Less than 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:
Pediatric Hematology
Job Summary:
JOB SUMMARY
Monitors the data functions and the conduct of research protocols with some guidance. Ensures the integrity and quality of clinical research is maintained.
.
KEY RESPONSIBILITIES
Follows policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research.
Implement policies, procedures, and regulations to know when a patient can/cannot be enrolled on a study and to report protocol non-compliance, adverse events, and serious adverse events.
Implementation, coordination, management and reporting of clinical/translational research operations.
Follow protocols and procedures to submit, review, and seek approval of protocol and protocol related documents. Must be able to review protocols and assist in the development of source documentation to capture data time points needed to obtain objectives of the protocol; train internal and external research staff on protocol and trial expectations as needed
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.
Will work with internal and external research staff on protocol expectations, reporting guidelines, elevate issues to PI of trial, FDA, and other governing bodies as needed to ensure human subjects protection.
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.)
Engages in a minimum of 10 hours of continuous, job-related educational activities annually. Actively seeks new learning opportunities, seeing learning as a part of work.
Key Function #4: Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.)
Specific Examples: Engages in a minimum of 10 hours of continuous, job-related educational activities annually. Actively seeks new learning opportunities, seeing learning as a part of work.
TECHNICAL CAPABILITIES
• Database Knowledge (Novice): Knowledge and understanding of a database and how data is organized so that its contents can easily be accessed, managed, and updated.
• Quality Assurance (Novice): 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 (Novice): 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 (Novice): 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.
• Data Analysis (Novice): The ability to analyze data in an accurate manner.
• Data Entry (Novice): The ability to transcribe information from the original source into an electronic system according to written and verbal instructions efficiently and accurately.
• Project Management (Novice): Planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives.
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: Delivers job responsibilities that impact own job area/team with some guidance. Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement. Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements. Team Interaction: Individually contributes to project/ work teams.
Core Capabilities :
Supporting Colleagues: - Develops Self and Others: Continuously improves own skills by identifying development opportunities.- Builds and Maintains Relationships: Seeks to understand colleagues priorities, working styles and develops relationships across areas. - Communicates Effectively: Openly shares information with others and communicates in a clear and courteous manner. Delivering Excellent Services: - Serves Others with Compassion: Invests time to understand the problems, needs of others and how to provide excellent service. - Solves Complex Problems: Seeks to understand issues, solves routine problems, and raises proper concerns to supervisors in a timely manner. - Offers Meaningful Advice and Support: Listens carefully to understand the issues and provides accurate information and support. Ensuring High Quality: - Performs Excellent Work: Checks work quality before delivery and asks relevant questions to meet quality standards.- Ensures Continuous Improvement: Shows eagerness to learn new knowledge, technologies, tools or systems and displays willingness to go above and beyond. - Fulfills Safety and Regulatory Requirements: Demonstrates basic knowledge of conditions that affect safety and reports unsafe conditions to the appropriate person or department. Managing Resources Effectively :- Demonstrates Accountability: Takes responsibility for completing assigned activities and thinks beyond standard approaches to provide high-quality work/service. - Stewards Organizational Resources: Displays understanding of how personal actions will impact departmental resources. - Makes Data Driven Decisions: Uses accurate information and good decision making to consistently achieve results on time and without error. Fostering Innovation: - Generates New Ideas: Willingly proposes/accepts ideas or initiatives that will impact day-to-day operations by offering suggestions to enhance them.- Applies Technology: Absorbs new technology quickly; understands when to utilize the appropriate tools and procedures to ensure proper course of action. - Adapts to Change: Embraces changes by keeping an open mind to changing plans and incorporates change instructions into own area of work.
Position Qualifications:
Responsibilities:
Certifications :
Work Experience :
Relevant Work Experience
Experience Level :
Less than 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