Clinical Research Coordinator- 260130

Medix™; Texas; On-site; USD 54,000 - 76,000; Full time

Job summary

Medix is seeking a detail-oriented Clinical Research Coordinator in Live Oak, TX to drive study operations, maintain protocol compliance, and manage active trial execution across a dynamic clinical caseload.

The role requires 3+ years of CRC experience, patient-facing research work (e.g., MA/EMT/Phlebotomy), and the ability to support multiple studies simultaneously, coordinating informed consent, IP handling, data entry, and regulatory communications, while upholding HIPAA and FDA GCP

Qualifications

• 3+ years of clinical research experience as a CRC.
• Experience in a patient-facing research role, or as a Medical Assistant, EMT, or Phlebotomist.
• Ability to support and manage at least 3 active studies simultaneously (industry-funded and IIT).

Responsibilities

• Coordinate all aspects of participant care from screening through study completion, including informed consent and education on IP use and safety.
• Dispense and administer IP and promptly report adverse events, deviations, and safety issues to the PI, Sponsor, and IRB.
• Perform data collection, source documentation, and entry into databases, sponsor CRFs, and IWRS with proper documentation.
• Collaborate with the clinical team and external partners to achieve target enrollment and efficient trial selection.
• Assist in site initiation meetings, monitoring visits, and regulatory inspections.
• Manage patient stipend payments and ensure HIPAA, FDA GCP, and QA guidelines compliance.

Skills

CRC experience

Multitask study management

Patient-facing research

Job description

We are seeking a detail-oriented and collaborative Clinical Research Coordinator in Live Oak, TX. You will drive study operations, maintain protocol compliance, and manage active trial execution across a dynamic clinical caseload.

Responsibilities

• Coordinate all aspects of participant care from screening through study completion, including administering detailed informed consent and providing protocol-based subject education on investigational product (IP) use and safety.
• Dispense and administer investigational product (IP) while promptly tracking and reporting adverse events, protocol deviations, and safety issues to the PI, Sponsor, and IRB.
• Perform accurate and timely data collection, source documentation, and entry into databases, sponsor CRFs, and IWRS, while maintaining Essential Documents.
• Collaborate closely with the clinical team and external industry partners to ensure efficient trial selection, patient recruitment, and achievement of target enrollment goals.
• Assist in the preparation and facilitation of site initiation meetings, monitoring visits, and regulatory authority inspections.
• Manage the patient stipend automated payment process and ensure strict adherence to HIPAA, FDA GCP, and internal quality assurance guidelines.

Required Skills

• 3+ years of clinical research experience as a CRC supporting investigational drug studies.
• Previous experience in a patient-facing research role, or experience as a Medical Assistant, EMT, or Phlebotomist.
• Proven ability to successfully support and manage at least 3 active studies simultaneously (industry-funded and IIT).