Nashville, TN, 37230, USA
1 day ago
Clinical Trials Associate 1, Pediatric Genetics
**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 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 is committed to an environment where everyone has the chance to thrive and where your uniqueness 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 Genetics **Job Summary:** JOB SUMMARY This position is with the Phillips Lab, within the Division of Genetics and Genomic Medicine at Vanderbilt University Medical Center. This CTA1 position will help the faculty and research nurses complete the ever-increasing volume of clinical trials in Peds Genetics. The person will enter study data, schedule patient visits including travel arrangements, file subject data, manage regulatory documents, order supplies for the clinical trials, prepare IRB forms, review and prepare invoices for the clinical trial studies, among other tasks related to clinical trial performance and maintenance. . KEY RESPONSIBILITIES Preparation and Coordination: + Knowledgeable of protocols in order to assist in creation of source documentation and study related forms as needed and prep/create binders for subject visits + Prepares kits for procedures and labels tubes with specific times and dates for collection. + Assists with monitoring compliance with protocol and regulations. + Ensures deadlines are met for study. + Schedule all patient visits with CRC and ancillary depts, patient families and travel vendors as needed for all visits + Must be knowledgeable of Word, Publisher and Excel Research Data Collection + Abstracts and records all patient data essential to the study onto required case report forms. + Inputs all pertinent patient data into database accurately. + Collects and monitors all study patients records to document treatments and outcomes as required by the protocol. + Reports all adverse reactions according to VUMC and protocol guidelines. + Calls or sends questionnaires to patient to check outcomes, survival rate, and quality of life. Maintaining Records + Ensures complete source documentation in record. + Meets with and assists in response to sponsors and monitors to ensure compliance with protocol and applicable regulations. + Ensures all regulatory and visit source documentation records are filed in the proper protocol binders and maintaining organization of these binders + Examine data and records to ensure compliance with protocol. TECHNICAL CAPABILITIES • Laboratory Practices (Novice): Possesses sufficient fundamental proficiency to successfully demonstrate laboratory practices in practical applications of moderate difficulty. Generally works under the direction of others while accomplishing assignments. • Medical Records Management (Novice): Knowledge of how and where to store and maintain basic records associated with job assignments. • 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 clearly defines tasks and methods described in detail to achieve standardized solutions that impact own performance with regular guidance. * Problem Solving/ Complexity of work: Follows a well established process to solve routine problems where solutions are clearly prescribed. * Breadth of Knowledge: Has basic job knowledge of systems and procedures that are common to own job. * Team Interaction: Individually contributes to the team. **Core Capabilities** **:** 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. 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 :** Associate's _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._
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