Clinical Research Coordinator II at ITERATIVE SCOPES INC

Southlake, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

14 May, 26

Salary

0.0

Posted On

13 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Protocol Management, Patient Recruitment, Informed Consent, Scheduling, Phlebotomy, Specimen Processing, IATA Regulations, CTMS System, Documentation, Good Clinical Practices, Safety Data Review, Data Verification, Quality Control, Monitor Visits, PHI Compliance

Industry

Hospitals and Health Care

Description

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. Clinical Research Coordinator II 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 - Level II (CRC II). 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 to meet enrollment targets on assigned studies 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; contribute and implement ideas to improve site performance Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality 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 3 years of clinical research experience Experience in phlebotomy preferred 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 CandidateAccommodations@iterative.health. 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 CandidateAccommodations@iterative.health.

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Responsibilities

The Clinical Research Coordinator II supports, facilitates, and coordinates daily clinical trial activities, including administrative and clinical management of industry-sponsored trials, problem-solving, and protocol adherence. Key duties involve leading patient recruitment, scheduling visits, conducting patient procedures like blood draws and ECGs, dispensing medication, and ensuring accurate documentation in the CTMS.