healthcare
Posted May 28Clinical Research Coordinator I - Port Arthur, TX
Port Arthur, United StatesOn-site
Responsibilities
- 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
- 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.
- 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
- Schedule and prepare for monitor visits
- Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
- Perform quality work within deadlines with or without direct supervision
Requirements
- By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
- Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
- 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
Experience
- Minimum 1-2 years of clinical research experience
Contact
- experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Additional details
- Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.
- The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies.
- The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies.
- Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services.
- The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Responsibilities:
- Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
- Dispense study medication, collect vital signs and perform ECGs
- Adhere to Research SOPs, Good Clinical Practices, and the study protocols
- 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