Clinical Research Coordinator I - Port Arthur, TX - Phlebotomist, MA & LPNs welcome!

Responsibilities

• Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
• Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
• Schedule all patient research visits and procedures consistent with protocol requirements
• Conduct patient visits as outlined within each study protocol
• Dispense study medication, collect vital signs and perform ECGs
• Perform blood draws, process and ship specimens per study protocol and IATA regulations
• Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
• Act as point of contact for study participants
• Adhere to Research SOPs, Good Clinical Practices, and the study protocols
• Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
• Ensure all safety data is reviewed by the PI in a timely manner
• Maintain inventory of study equipment and supplies onsite at all times
• Participate actively in communication of status and results to management
• Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
• Schedule and prepare for monitor visits
• Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

Qualifications

• Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
• Minimum 1-2 years of clinical research experience
• Able to execute on research tasks with guidance from more experienced staff, PIs, and management
• Strong written and verbal communication skills
• Ability to read, interpret, and apply clinic policies and research protocols
• Ability to use standard office software
• Must be able to lift up to 25 pounds