Research Assistant II

Summary:

The Clinical Research Data Coordinator plays a critical role in supporting the successful execution of clinical trials at Christus St. Vincent Regional Medical Center. This position is primarily responsible for accurate and timely data entry, evaluation, and quality control of clinical trial data across all protocols. This includes evaluating data prior to entry into centralized systems, tracking patient participation, and implementing quality control measures to ensure data integrity and completeness. Key responsibilities include resolving data queries, correcting errors, and ensuring outstanding data is submitted promptly and acting as a liaison between the site and central data management teams to maintain data integrity and completeness. Compliance with study protocols, ICH/GCP guidelines, federal regulations, and sponsor requirements is essential.

In addition to data management, this position assists with essential laboratory and technical tasks to support clinical trial operations. Duties include administrative support, specimen handling, processing, and transport; as well as reviewing lab results and maintaining inventory. The Clinical Research Data Coordinator works collaboratively with Clinical Research Coordinators, site management, investigators, sponsors, and monitors to ensure productivity, regulatory compliance, and the timely and successful completion of studies.

Responsibilities:

• Responsible for data management for clinical trials data.
• Records collected subject data promptly and efficiently into study data system while maintaining HIPAA compliance.
• Reviews subject charts for completeness and accuracy while entering subject data.
• Ensure all corrections made by study coordinator in subject chart are legible and compliant with GCP guideline
• Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant medications, etc.) study visits
• Transcribe subject study information from source documents to the Electronic Case Report Forms
• Review study database regularly to ensure data is being entered in a timely manner and queries are being addresses/resolved.
• Report instances of chart incompleteness and inconsistencies to lead study coordinator and/or site management.
• Attends site initiation visits for data entry training as required.
• Communicates with site management and lead study coordinator to ensure there are no delays or issues with data entry during study start-up, study administration, and study closeout.
• Assist Clinical Research Coordinators as needed with filing, chart set up and clinical supplies for organization.
• Develops protocol-specific source documentation and organizes and prepares research materials for research study visits.
• Assist in preparation for monitoring visits and audits.
• Obtain any applicable additional/required sponsor training and/or certifications
• In addition to study databases, provides accurate and timely data collection, documentation, entry, and reporting in CSV and CHRISTUS Health databases and systems
• Assist with the day-to-day operations of clinical trials and studies.
• Responsible for sample preparation, processing, documentation, and shipping of specimens and maintenance of study supplies and kits.
  • Order and receive drug/device supplies.
  • May assist in eligibility screening
  • Reviews and may obtain patient consent
  • Perform other duties as required and/or assigned.
  • Maintains consistency with Administrative and Departmental policies with appropriate behavior, dress, attitude, attendance, confidentiality, professionalism, and reliability.

Requirements:

Education:

• High School Diploma or equivalent required.
• Bachelor's Degree in Healthcare Administration, Research, Biology, Business or related field preferred.

• CERTIFICATION/LICENSES: Certificate of training in Good Clinical Practice must be completed within 1 month of hire.

Experience:

• * Two (2) years of clinical research or related experience OR 2 years of data entry experience in a professional setting.

  • Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) preferred.
  • Experience with REDCap preferred.
  • Familiarity with research and medical terminology preferred
  • Experience supporting clinical research projects preferred

Work Schedule:

Monday - Friday 8am to 5pm

Work Type:

Full Time