Clinical Research Coordinator I - Bellevue
About The Position
Iterative Health is a healthcare technology and services company focused on accelerating clinical research to transform patient outcomes. 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. The company drives the success and growth of its partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, Iterative Health empowers research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. The company is seeking a full-time, experienced Clinical Research Coordinator (CRC) to support, facilitate, and coordinate daily clinical trial activities, playing a critical role in the conduct of studies.
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 skils
- 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 Haves
- Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
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
- Cooperate 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
