Iterative Health is looking to hire a Clinical Research Coordinator to coordinate and administer research study activities, ensuring compliance with regulatory requirements, good clinical practices, and human subject protection. The role aims to accelerate the path to market for novel therapies by empowering research teams and study sponsors.
Requirements
- One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required.
- Clinical experience in an office or hospital setting.
- Research experience or equivalent.
- Basic Life Support certification required.
- Knowledge of medical terminology, anatomy, physiology, and pathophysiology.
- Familiarity with health care systems, regulations, policies, and functions.
- Understanding of clinical research documentation standards.
Responsibilities
- Administratively and clinically manage industry sponsored clinical trials.
- 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 patient against inclusion/exclusion criteria of studies.
- Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations.
- Dispense study medication, collect vital signs, and perform ECGs.
- Complete and maintain case report forms per FDA guidelines and review them against the patient’s medical record for completeness and accuracy.
Other
- Adhere to Research SOP’s, Good Clinical Practices, and the study protocols.
- Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes.
- Act as a resource for other staff members regarding investigational issues or guidelines.
- Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved.
- Adopt the One GI culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers.
