Clinical Research Coordinator I - Port Arthur, TX - Phlebotomist, MA & LPNs welcome!
Iterative Health · Lake Charles, LA · 2 wk ago
On-siteAnalystFull-time
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide. We are seeking a full-time, experienced Clinical Research Coordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Open to relocation 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 documentationSchedule all patient research visits and procedures consistent with protocol requirementsConduct patient visits as outlined within each study protocolDispense study medication, collect vital signs and perform ECGsPerform blood draws, process and ship specimens per study protocol and IATA regulationsEnsure 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 participantsAdhere to Research SOPs, Good Clinical Practices, and the study protocolsMaintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the studyEnsure all safety data is reviewed by the PI in a timely manner Maintain inventory of study equipment and supplies onsite at all timesParticipate 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 protocolSchedule and prepare for monitor visitsAssists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulationsCooperates 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 accuracyIterative Health ExpectationsAll employees are expected to: Perform quality work within deadlines with or without direct supervisionInteract professionally with other employees, customers and suppliersWork effectively as a team contributor on all assignmentsWork independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizationsQualificationsMedical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferredMinimum 1-2 years of clinical research experienceAble to execute on research tasks with guidance from more experienced staff, PIs, and managementStrong written and verbal communication skilsAbility to read, interpret, and apply clinic policies and research protocolsAbility to use standard office softwareMust be able to lift up to 25 poundsAt 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 CandidateAccommodations@iterative.health. 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 CandidateAccommodations@iterative.health.