Clinical Research Assistant - Port Arthur, TX

Where You'll Drive Impact

• Assist the Study Team with communicating study requirements to all individuals involved in the study.
• Work with the Study Team to develop and implement recruitment strategies in accordance with site policies and IRB requirements.
• Assist with screening subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
• Assist with registering participants in the Clinical Trial Management System (CTMS) to ensure proper billing of study procedures to the appropriate funding source.
• Collect and report ongoing patient recruitment and enrollment progress and metrics to site management and the PI.
• Assist the Study Team in completing study documentation and maintaining study files in accordance with sponsor requirements and site policies, including consent forms, source documentation, case report forms, and investigational material accountability forms.
• Enter all patient visit data in eCRF and CTMS on a daily basis or as directed.
• Arrange secure storage of study documents in accordance with GCP guidelines or the contracted length of time, whichever is longer.
• Maintain inventory of study supplies; follow sponsor protocol and site policies on investigational drug/device accountability when applicable.
• Process and ship specimens per study protocol and IATA regulations as directed.
• Work with the Study Team to manage the day-to-day activities of the study, including problem-solving, communication, and protocol management.
• Aid the Study Team in maintaining effective and ongoing communication with sponsors, research participants, site management, and the PI throughout the course of each study.
• Assist the Study Team in protecting the rights and welfare of all human research participants in accordance with federal regulations.
• Cooperate with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI; report instances of noncompliance to the appropriate compliance office.
• Perform job related duties as requested

What You Bring to the Team

• High school diploma or equivalent required; some college coursework preferred.
• Minimum 2 years of experience in a healthcare setting.
• Strong written and verbal communication skills.
• Ability to read, interpret, and apply clinic policies and research protocols.
• Proficiency in standard office software; familiarity with CTMS or eCRF platforms a plus.
• Highly organized with the ability to manage multiple tasks and meet deadlines.
• Ability to work both independently and collaboratively as part of a research team.
• Professional, detail-oriented, and committed to maintaining confidentiality and data integrity.

Preferred Qualifications

• Prior clinical research experience or exposure to clinical trial operations.
• Familiarity with GCP guidelines and human subject research regulations.
• Experience with specimen processing and shipping per IATA regulations.
• Interest in pursuing a career path in clinical research coordination or research operations.

Physical Requirements

• Ability to sit, stand, and move throughout clinical and office environments for extended periods of time
• Ability to lift and move up to 25 pounds as needed

Additional information

At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact.