Iterative Health is a healthcare technology and services company dedicated to accelerating clinical research to improve patient outcomes. The Iterative Health Site Network is a premier network of over 70 clinical research sites across the US and Europe, focused on advancing gastrointestinal (GI) and hepatology novel therapies. Our mission is to drive the success and growth of our partner sites by providing them with tech-enabled services. Combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to innovative therapeutics for patients in need.

All employees are expected to perform quality work within deadlines, with or without direct supervision, and to interact professionally with colleagues, customers, and suppliers. They should work effectively as team contributors on all assignments, while also being capable of working independently and coordinating efforts with others.

Position Purpose

The Clinical Research Coordinator (CRC) is a specialized research professional working under the direction of the Director and Clinical Principal Investigator (PI). The CRC supports, facilitates, and coordinates daily clinical trial activities and plays a critical role in the conduct of the study.

Responsibilities, Duties, Functions, and Tasks

• Communicate study requirements to all individuals involved in the study.
• Develop and implement recruitment strategies in accordance with Impact Research and IRB requirements and approvals.
• Screen subjects for eligibility using protocol-specific inclusion and exclusion criteria.
• Enter participant information and study visit procedures into the Clinical Trial Management System to ensure billing to the appropriate funding source.
• Maintain adequate inventory of study supplies.
• Follow sponsor protocol and Impact Research policy on investigational drug/device accountability when handling investigational drugs/devices.
• Complete study documentation and maintain study files according to sponsor requirements and Impact Research policies, including consent forms, source documentation, narrative notes (if applicable), case report forms, and investigational material accountability forms.
• Maintain effective communication with sponsor, research participants, Director, and PI throughout the study.
• Manage daily study activities, including problem solving, communication, and protocol management.
• Collect and report ongoing patient recruitment/enrollment metrics to Director and PI.
• Arrange secure storage of study documents, maintaining them according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer.
• Protect the rights and welfare of all human research participants in accordance with Federal regulations.
• Cooperate with Impact Research compliance and monitoring efforts regarding access, use, and disclosure of PHI, and report noncompliance instances to the appropriate compliance office.
• Perform other duties as assigned.

Qualifications

• Education: High school diploma or GED required; an associate degree from an accredited university is preferred.
• Experience: Minimum of 4 or more years of clinical research experience.
• Other Requirements: CRC certification is preferred.

Performance Requirements

• Knowledge of grammar, spelling, and punctuation.
• Knowledge of purchasing, budgeting, and inventory control.
• Skill in taking and transcribing dictation and operating office equipment.
• Skill in answering phones and responding to questions.
• Skill in time management, prioritization, and multitasking.
• Effective written and oral communication skills.
• Ability to work under pressure, communicate clearly, and present information effectively.
• Ability to read, interpret, and apply clinic policies and procedures.
• Problem-solving skills, with the ability to organize and analyze information.
• Ability to multi-task, establish priorities, and coordinate work activities.
• Proficiency in Microsoft Office (Word, PowerPoint, Excel) and relevant practice management software.
• Must be able to lift up to 25 lbs.
• Must be able to travel and hold a valid MVR.

Equipment Operated

Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment

This position is based in a well-lit medical office environment. Occasional evening and weekend work may be required.

Physical Requirements

Must possess the physical and mental abilities to perform tasks such as sitting for 90% of the day, operating office machines, stooping, bending, and mobility for errands or deliveries. Stress may be triggered by staff demands and deadlines.

At Iterative Health, we are committed to creating an environment that reflects the diversity of the patients our technology serves. We focus on building an equitable and inclusive culture and hiring process. If you require accommodations to make the application or interview process more accessible, please contact [email protected].