Clinical Research Coordinator I - Port Arthur, TX

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. We are seeking a full-time, experienced Clinical Research Coordinator (CRC).

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

Requirements

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

Nice to have

Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred