Clinical Research Coordinator I - RN - Port Arthur & Beaumont, TX - Temp/ PRN Role

Where You’ll Drive Impact

• Administratively and clinically manage industry-sponsored clinical trials, including problem-solving, communication, and protocol management.

• Schedule all patient research visits and procedures in accordance with protocol requirements.

• Ensure relevant study and subject-specific information is entered into the CTMS on a regular basis.

• Complete and maintain study documentation including consent forms, source documentation, progress notes, case report forms, and investigational accountability forms.

• Complete and maintain case report forms per FDA guidelines, reviewing them against patient medical records for completeness and accuracy.

• Schedule and prepare for monitor visits.

• Maintain inventory of study equipment and supplies onsite at all times.

• Lead patient recruitment activities including chart reviews, protocol discussions with patients, and verification of informed consent documentation.

• Conduct patient visits as outlined within each study protocol.

• Act as the primary point of contact for study participants throughout the course of the study.

• Dispense study medication, collect vital signs, and perform ECGs per protocol.

• Perform blood draws; process and ship specimens per study protocol and IATA regulations.

• As assigned: place IVs, administer IV medications and fluids, give intramuscular and subcutaneous injections, monitor patients during infusion, and discharge patients in accordance with protocol and site policies.

• Adhere to Research SOPs, Good Clinical Practice (GCP) guidelines, and study protocols at all times.

• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocols.

• Ensure all safety data is reviewed by the PI in a timely manner.

• Cooperate with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI; report instances of noncompliance to the appropriate compliance office.

• Assist the study team in protecting the rights and welfare of all human research participants in accordance with federal regulations.

• Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager, and PI throughout the course of each study.

• Actively participate in communication of status and results to management.

• Perform job related duties as requested

What You Bring to the Team

• Active Registered Nurse (RN) license required.
• 1–2 years of clinical research experience strongly preferred.
• Solid nursing background with a concentration in, or willingness to develop advanced knowledge of, GI specialty.
• Ability to execute research tasks with guidance from experienced staff, PIs, and management.
• Strong written and verbal communication skills.
• Ability to read, interpret, and apply clinic policies and research protocols.
• Proficiency in standard office software and CTMS platforms.
• Highly organized with the ability to manage multiple priorities and meet deadlines.
• Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications

• Prior GI or hepatology clinical research experience.
• Familiarity with GCP guidelines and FDA regulations governing clinical research.
• Experience with CTMS, EDC, or eTMF platforms.
• ACRP or SOCRA certification (CCRC or CCRP), or active pursuit of certification.