Clinical Research Associate 2-Vanderbilt Ingram Cancer Center

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 60

Job Summary:
Responsible for aspects of study site monitoring including close-out of clinical sites, maintenance of study files, conducting pre-study and initiation visits, assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with established guidelines with occasional guidance.

Department Summary:

Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 51 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support.

KEY RESPONSIBILITIES
• Ensure study staff who will conduct the protocol have received proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Carefully review documents to ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools.
• Ensure the resources of the funder and Vanderbilt University Medical Center are spent wisely by performing the required monitoring tasks in an efficient manner according to established SOPs and guidelines
• Review case report form, query generation and resolution against established monitoring plan guidelines, with or without direct supervision, on Vanderbilt University Medical Center data management systems
• Assist in recruitment/review of investigators, collecting investigator documentation and site management
• Update, track and maintain study-specific trial management tools/systems
• Generate and track drug shipments and supplies as needed
• Coordinate slot allocation/randomization of study patients across all sites, providing timely study updates as needed to all applicable site personnel.
• Develop clinical research materials (slides, reports, charts, etx.) and assist with site/study audit preparation and follow up on Corrective Action Plan responses as needed
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES
• Clinical Research (Novice): Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues.
• Project Tracking & Reporting (Novice): The ability to track the progress of a project and report on the status.
• Research Administration (Novice): 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.

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: Performs tasks that are typically routine that may impact team's performance with occasional guidance. * Problem Solving/ Complexity of work: Utilizes some discretion and research to solve routine problems. * Breadth of Knowledge: Applies knowledge of standards, established processes and procedure that apply to your own job. * Team Interaction: Provides guidance to entry level co-workers.

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 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. - 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 :
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