Clinical Trials Associate 1

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Organization:

Pediatric Infectious Disease

Job Summary:

JOB SUMMARY

This position is with the VISPR Program, formerly called 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.

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KEY RESPONSIBILITIES

This position will perform a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials. Assists in ensuring adherence to protocols, appropriate regulations, and deadlines. Ensures quality of information received.

• Screening patients to determine the ones who are eligible for enrollment in the clinical trial.

• Thoroughly explaining study procedures and schedule to patients.

• Performing all procedures necessary for each clinical visit per protocol.

• Abstract and record all patient data essential to the study in record and on REDCap in a timely manner.

• Scheduling upcoming visits within window.

• Sending a daily wrap-up email of visits to team members.

• Updating the visit log daily.

• Follow-up of study patients in between visits, monitoring any new symptoms or adverse events post vaccination, continuous review of patients’ health status and communicating with them as needed.

• Processing the payment checks for participants and sending them in a timely manner.

• Entering billing notes into Epic.

• Preparing binders and lab kits for all upcoming visits.

• Tracking all supplies necessary for the study and requesting new supplies as needed.

• Training new team members on the study protocol and procedures.

• Updating site study status weekly.

• This position will perform a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials.

• Assists in ensuring adherence to protocols, appropriate regulations, and deadlines

• Ensures quality of information received

• Preparation and Coordinating

• 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

• Informs nurse of tests and procedures as needed

• Conducts follow-up of study patients

• Ensures deadlines are met for study

• Collecting Data and Coordinating

• Abstracts and records all patient data essential to the study onto required case report forms.10

• 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

• 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

• Generally works under the direction of others while accomplishing assignments

TECHNICAL CAPABILITIES

• Medical Records Management (Novice): Knowledge of how and where to store and maintain basic records associated with job assignments