Clinical Research Coordinator I - Houston, TX

Seae Ventures; Houston (TX); On-site; USD 60,000 - 85,000; Full time

Job summary

Iterative Health is seeking a full-time Clinical Research Coordinator - Nurse to support, facilitate and coordinate daily clinical trial activities and play a critical role in study conduct. The role involves communicating study requirements, screening subjects, and entering data into the trial management system to ensure proper funding and billing.

The CRC-RN will maintain study documentation, monitor investigational products, and ensure compliance with sponsor requirements, IRB approvals, and

Qualifications

• RN license required.
• 1-3 years of Clinical Research Coordinating experience preferred.

Responsibilities

• Communicate study requirements to all individuals involved in the study.
• Develop and implement recruitment strategies in accordance with GI Alliance RESEARCH and IRB requirements and approvals.
• Pre-screen and Screen subjects for eligibility using protocol specific inclusion and exclusion criteria.
• Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding sources.
• Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or GI Alliance RESEARCH Policy on Investigational Drug/Device Accountability.
• Complete study documentation and maintenance of study files in accordance with sponsor requirements and GI Alliance RESEARCH policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Maintains effective and ongoing communication with sponsor, research participants, site manager, Regional Director, and PI during the course of the study.
• Manage the day to day activities of the study including problem solving, communication and protocol management.
• Collects and reports ongoing patient recruitment/ enrollment metrics to site manager and PI.
• Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
• Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with GI Alliance RESEARCH compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
• Other duties as assigned.

Skills

RN license

CRC experience

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.

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 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. 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.

We are seeking a full-time, experienced Clinical Research Coordinator - Nurse. The CRC-RN supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Responsibilities/Duties/Functions/Tasks:

• Communicate study requirements to all individuals involved in the study.
• Develop and implement recruitment strategies in accordance with GI Alliance RESEARCH and IRB requirements and approvals.
• Pre-screen and Screen subjects for eligibility using protocol specific inclusion and exclusion criteria.
• Entry of participant information and study visit procedures into the Clinical Trial Management System to ensure billing to appropriate funding sources.
• Maintains adequate inventory of study supplies. When handling investigational drugs/devices, follows the sponsor protocol and/or GI Alliance RESEARCH Policy on Investigational Drug/Device Accountability.
• Complete study documentation and maintenance of study files in accordance with sponsor requirements and GI Alliance RESEARCH policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Maintains effective and ongoing communication with sponsor, research participants, site manager, Regional Director, and PI during the course of the study.
• Manage the day to day activities of the study including problem solving, communication and protocol management.
• Collects and reports ongoing patient recruitment/ enrollment metrics to site manager and PI.
• Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
• Protects the rights and welfare of all human research participants involved in research in accordance with Federal regulations
• Cooperates with GI Alliance RESEARCH compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
• Other duties as assigned.

Qualifications and experience

• RN license required
• 1-3 years of Clinical Research Coordinating experience preferred

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 [e-mail].