Clinical Research Data Specialist

University of Colorado•Aurora, CO

1d•Onsite

About The Position

The Clinical Research Data Specialist will be responsible for the management of clinical trials data for all protocols conducted at the Infectious Diseases Clinical Trials Unit. This includes evaluation of clinical trials data prior to entry into a centralized data management system; randomization of research participants to protocol specified treatments; tracking patient participation through systems developed locally; development and implementation of quality control mechanisms for ensuring data accuracy and completeness; acting as a liaison between the site and the central data management center for ensuring quality of data by resolving data queries, errors and submission of outstanding data in a timely manner.

Requirements

Bachelor’s degree in any field.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.
One (1) year clinical research or related experience.
Applicants must meet minimum qualifications at the time of hire.
Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Knowledge of basic human anatomy, physiology, and medical terminology.
Ability to interpret and master complex research protocol information.
Proficiency in Microsoft Office Suite.

Nice To Haves

Bachelor’s degree in science or health related field.
Two (2) years of clinical research or related experience.
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
Experience with REDCap.

Responsibilities

Assist with and oversee the day-to-day operations of clinical trials and studies.
Responsible for data management for all clinical trials data.
Develops protocol-specific source documents and organizes and prepares research materials for research study visits.
Accurately and timely enters clinical trials data into centralized data management systems, ensures data quality and reviews participant records for completeness, accuracy, and quality.
Reviews and resolves data discrepancies in data management systems.
Independently masters study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.
Independently performs study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities.