Iterative Health is looking for 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 conduct clinical drug trials while maintaining patient safety, confidentiality, and high professional standards, ultimately contributing to the acceleration of clinical research and the development of novel therapies.
Requirements
- One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required.
- Previous GI trials experience preferred.
- 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.
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.
- Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol.
Other
- Adhere to Research SOP’s, Good Clinical Practices, and the study protocols.
- Complete and maintain case report forms per FDA guidelines and review them against the patient’s medical record for completeness and accuracy.
- Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes.
- Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients.
- Maintain compliance of protocols and regulatory guidelines for studies performed in the research area.
