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 70+ clinical research sites across US and Europe 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.
Company Conformance Statements
- 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.
Position purpose
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Director and Clinical Principal Investigator (PI). The CRC 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 Impact Research and IRB requirements and approvals.
- 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 source.
- Maintain adequate inventory of study supplies and follow sponsor protocols when handling investigational drugs/devices.
- Complete study documentation and maintenance of study files according to sponsor requirements and policies.
- Maintain effective and ongoing communication with sponsor, research participants, Director and PI during the study.
- Manage day to day activities of the study 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 per Good Clinical Practice guidelines or contracted length of time.
- Protect rights and welfare of all human research participants in accordance with Federal regulations.
- Cooperate with Impact Research compliance and monitoring efforts regarding use and disclosure of PHI.
- Other duties as assigned.
Qualifications
- Education: High school diploma/GED required; Associate's degree preferred.
- Experience: Minimum 1-2 years of clinical research experience.
- Skills: Knowledge of grammar, spelling, punctuation, purchasing, budgeting, inventory control; computer skills (Microsoft Office and practice management software); ability to multitask, communicate effectively, work under pressure, and apply clinic policies.
- Must be able to lift up to 25 lbs and travel as needed.
Work Environment and Physical Requirements
Position is in a well-lighted medical office environment with occasional evening and weekend work. Requires sitting for 90% of the day, manual dexterity to operate office equipment, and ability to handle files and deliveries. Stress may be due to multiple demands and deadlines.
