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

Job Description

Reports To: Manager, Clinical Research

Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards.

FLSA: Non-Exempt

Supervisory Responsibility: This position has no supervisory responsibilities

 

Key Responsibilities

• Administratively and clinically manage industry sponsored clinical trials.
• Adhere to Research SOP’s, Good Clinical Practices, and the study protocols.
• 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.
• Schedule all patient research visits and procedures consistent with protocol requirements.
• 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.
• Complete and maintain case report forms per FDA guidelines and review them against the patient’s medical record for completeness and accuracy.
• Function in a clinical role by conducting clinical research studies.
• 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.
• Act as a resource for other staff members regarding investigational issues or guidelines.
• Coordinate the availability and distribution of medications for patients in a timely manner.
• Perform phlebotomy for lab work as required and completes all necessary forms.
• Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved.
• Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures.
• Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects.

 

• Plan and coordinate with the research director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.
• Plan, implement, and maintain data collection and analysis systems in support of the research protocol.
• Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies.
• Facilitate assigned clinical trial from start to finish.
• Screen participants for all studies independently.
• Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
• Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required.
• Adhere to infection control/safety guidelines and confidentiality policies.

 

Core Competencies

• Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized, Self-motivated

 

General

• Adopt the One GI culture of respect, integrity and accountability that contribute to an