Clinical Research Data Specialist I

Texas A&M University Health Science Center; Corpus Christi (TX); On-site; USD 38,000 - 46,000; Full time

Benefits offered by this job

Medical insurance

Prescription drug coverage

Dental insurance

Vision insurance

Life and AD&D insurance

Flexible spending accounts

Paid holidays

Paid sick leave

Paid vacation

Retirement benefits

LinkedIn Learning access

Job summary

Texas A&M University Health Science Center Research Specialist I role based in Corpus Christi supports clinical research, compiling data, performing projections, and aiding the PI and staff in daily activities.

The position reports to IBT in Houston and may require weekend/evening work, travel, and is grant-funded. Collaboration with investigators and compliance with regulatory standards are essential.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• Four years of related experience in a specialized and relevant field of research.
• Experience working in a physician practice, hospital, oncology clinic, or other healthcare environment.
• Experience with electronic data capture (EDC) systems and regulatory documentation.
• Current CITI Human Subjects Protection (HSP) training certification or equivalent, or the ability to obtain certification upon hire.
• Knowledge, Skills, and Abilities Ability to multitask and work cooperatively with others.
• Knowledge of word processing, spreadsheet, database, and presentation applications.
• Interpersonal and communication skills.
• Planning and organization skills.
• Familiarity with appropriate laboratory and/or technical equipment.
• Ability to effectively utilize a computer and applicable software.
• Attention to detail.
• Knowledge of FDA regulations, Good Clinical Practice (GCP), HIPAA, and human subject protections.
• Proficient computer skills, including Microsoft Office Suite and electronic medical record (EMR) systems.

Responsibilities

• Data Analysis and Testing Compiles and reviews data and metadata.
• Collects samples and measurements for experiments.
• Implements and maintains data collection and summarization of clinical trials.
• Computes projections.
• Performs analysis and tests.
• Makes and records observations and scientific measurements.
• Assist with collection, processing, shipping, and tracking of research specimens.
• Assist in preparing for sponsor monitoring visits, audits, and inspections.
• Track enrollment, follow-up, and protocol compliance.
• Maintain HIPAA compliance and participant confidentiality.
• Screen potential participants for eligibility according to study protocols.
• Schedule participant visits and study-related appointments.
• Assist with participant recruitment and retention.
• Enter study data into electronic databases and EMRs.
• Research Publications Utilizes summarized results in scientific and/or clientele-oriented publications.
• Prepares and writes proposals to funding agencies and maintains financial accounts related to research projects.
• Prepare study materials and participant packets.
• Maintain research records, regulatory binders, and study documentation.
• Executes assigned protocols in accordance with research-governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.
• Training Trains undergraduate and/or graduate students and other laboratory, technical or clinical staff involved in research.
• Develops and maintains training materials for external users.
• Purchasing Monitors and tracks all lab-related supplies and inventory levels.
• Purchases lab supplies, equipment, and services for the project.
• Assists with Rural Oncology Grant invoice processing based on the sub-awardee needs.

Skills

Multitask

Interpersonal skills

Microsoft Office

EMR systems

Education

Bachelor’s degree

Equivalent combination of education and experience

Tools

EDC systems

Regulatory documentation

Job description

Texas A&M University Health Science Center Research Specialist I role based in Corpus Christi supports clinical research, compiling data, performing projections, and aiding the PI and staff in daily activities.

The position reports to IBT in Houston and may require weekend/evening work, travel, and is grant-funded. Collaboration with investigators and compliance with regulatory standards are essential.