Associate Clinical Research Data Specialist, Pediatric Hematology

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.

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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): Use