Clinical Research Coordinator I - Port Arthur, TX

Job Description

Job Description

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.

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

Iterative Health Expectations

All employees are expected to:

• Perform quality work within deadlines with or without direct supervision
• Interact professionally with other employees, customers and suppliers
• Work effectively as a team contributor on all assignments
• Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations

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 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

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 View email address on us.fitly.work.

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 View email address on us.fitly.work.