Clinical Trials Associate I - Peds Infectious Disease

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Organization:

Pediatric Infectious Disease

Job Summary:

Job Summary:

This position is with the Halasa/Chappell Lab, jointly led by Drs Natasha Halasa and Jim Chappell, within the Division of Pediatric Infectious Diseases at Vanderbilt University Medical Center. Our laboratory research concentrates on the etiology, epidemiology, prevention, and pathobiology of infectious diseases.

This position performs a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials with regular guidance. Assists in ensuring adherence to protocols, appropriate regulations, and deadlines.

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KEY RESPONSIBILITIES

Preparation and Coordination –

• Knowledgeable of protocols in order to determine specific criteria for eligibility or exclusion.

• Sets up timeline of tests and required procedures.
• Prepares kits for procedures and labels tubes with specific times and dates for collection.
• Assists with monitoring compliance with protocol and regulations.
• Informs nurse of tests and procedures as needed.
• Conducts follow-up of study patients.
• Ensures deadlines are met for study.

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.
• 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 c