Clinical Research Coordinator
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.
Job description
We are seeking a full-time, experienced Clinical Research Coordinator. The Research Coordinator will facilitate all facets of gastrointestinal clinical research studies.
Responsibilities:
- Administratively and clinically manage industry-sponsored clinical trials
- Adhere to Research SOP's, Good Clinical Practices and the study protocols
- Participate actively in the communication of status and results to senior management
- Assist in training site personnel in regulatory, lab procedures, and general study-related training
- Assist in patient recruitment by performing detailed chart reviews and patient interviews
- Discuss study protocols with patients and verify the informed consent documentation
- Review medical history of patients against the Inclusion/Exclusion Criteria of studies
- Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations
- Schedule all patient research visits and perform procedures consistent with protocol requirements (Dispense study medication, collect vital signs and perform ECGs, etc)
- Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
- Maintain contact with clients and resolve any issues or questions for which the client made inquiries
- Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
- Ensure the filing and maintenance of all regulatory documents
- Schedule and prepare for monitor visits
- Assist with Practice focus on improving patient satisfaction and the patient experience
- Assist in preparing a brief monthly report on key indicators and issues
Qualifications
- Medical Assistant or LPN required, Associates degree in a clinical or scientific-related discipline preferred
- 1+ years previous experience as a clinical research coordinator for pharmaceutical phase II or III trials, GI trials experience preferred
- Computer skills - Microsoft Word, Excel, Power Point, CTMS, EMR
- Previous experience in a role of complex administration or project coordination
- Effective communication skills to include written, verbal and presentation skills
- Strong attention to detail and organizational, analytical, and problem solving skills
- Periodic local travel to other practice locations on an as-needed basis
Physical Requirements
- Ability to stand and walk throughout the day
- Prolonged periods of sitting and performing administrative duties, including the use of computers
- Ability to bend, twist, stoop, and reach
- Able to lift and carry supplies and equipment as needed (up to 15 pounds)
Job Type: Full-time
Schedule:
- Full Time
- Monday to Friday
Education:
- High school or equivalent (Preferred)
- Associate/Bachelors of Nursing, or LPN preferred.
Experience:
- 1 plus year in nursing preferred.
Work Location: In person
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 [click to reveal email address].