Clinical Trials Associate 1 - On Site

Vanderbilt University Medical Center•Nashville, TN

1d•Onsite

About The Position

In your pivotal role as Clinical Trials Associate, you will perform a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials with regular guidance. This can involve cold calling, so you must be comfortable talking with strangers. You also will assist in ensuring adherence to protocols, appropriate regulations, and deadlines. The specialists at Vanderbilt Otolaryngology–Head & Neck Surgery are worldwide leaders in research. As pioneers in the otolaryngology field, our discoveries are making a significant impact on science, as well as changing surgical and treatment options available to patients. Vanderbilt Otolaryngology-Head & Neck Surgery typically ranks between second and third in the nation for NIH grant funding. Our programs focus on academics, science, and patient care that translates into top-tier research and clinical trial options for our patients. 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.

Requirements

Associate’s Degree (or equivalent experience)
Excellent communications skills, both written and verbal
Experience working with children in a professional setting
Comfort with cold calling
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.

Responsibilities

Assesses patient eligibility for approved studies (10%) -Knowledgeable of protocols in order to determine specific criteria for eligibility or exclusion.
Ensures participant consent/assent forms are completed.
Reviews medical record to determine eligibility status.
Enters study participant data and follows study protocols (50%).
Records all participant data essential to the study into REDCap databases.
Follows study protocols for data collection and participant contact.
Reports all adverse events according to VUMC and protocol guidelines.
Creates reports as needed.
Assists with monitoring compliance with protocol and regulations.
Ensures deadlines are met for study (20%)
Schedules shipping of study materials to meet protocol deadlines.
Coordinates with clinic staff to ensure that data collection does not disrupt clinic flow.
Prepares study materials for mailing (e.g., study binders, retention items).
Attends weekly lab meetings and provides updates on participant’s status.
Collects follow-up data from study participants (20%).
Calls or sends questionnaires to participants to complete questionnaires.
Checks clinic schedules for upcoming data collection.