JOB SUMMARY:

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.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in any field.
• One (1) year clinical research or related experience.
  Applicants must meet minimum qualifications at the time of hire.

PREFERRED QUALIFICATIONS:

• 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.

KNOWLEDGE, SKILLS, AND ABILITIES:

• 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.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.
• Proficiency in Microsoft Office Suite.

• 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.
• Assists Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives.
• Adhere to research regulatory standards.
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities.
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives.