Clinical Research Coordinator I

This position supports Frenova Renal Research

PURPOSE AND SCOPE:

This position supports Frenova Renal Research

Conceptually applies the research protocol to the clinical setting, seeing subjects in a clinical and dialysis setting.

Maintains appropriate documentation associated with the assigned clinical study.

Performs all duties as delegated and supervised by the PI and governed by Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.

Complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

General Administrative


* Continues to display a mastery of Senior Clinical Research Associate duties and responsibilities


* Adheres to Standard Operating Procedures (SOP), GCP, all regulatory practices as established by law, and company policies and procedures


* Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with Food and Drug Administration (FDA), GCP, and ICH Guidelines


* In collaboration with the PI, incorporates knowledge of protocol to identify potential study participants according to inclusion/exclusion criteria


* Develops processes for monitoring the status of study subjects as they progress through the study protocol assessment timeline


* Maintains up-to-date knowledge for operation and use of study specific equipment and technology


* Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of them during participation in a clinical trial


* Serves as an advocate for human subjects by establishing repour with participants through open, transparent communication


* Educates the subject on study protocol and procedures


* Maintains the study site files according to GCP


* Maintains subject participant records according to GCP


* Demonstrates initiative and actively seeks new opportunities for continuous learning by attendance at educational and professional development training opportunities

Conduct of Research


* Reviews source document templates for protocol accuracy identifying any errors or improvements needed to be made for data integrity prior to subject screening


* Performs tasks required by a protocol, which may include obtaining medical history, phlebotomy, Electrocardiogram (EKG), and other required tests, assessments, or procedures


* Develops in depth knowledge of study-specific requirements for reporting subject safety issues to the sponsor, institutional review board (IRB), FDA, and other regulatory agencies.


* Monitors, detects, and reports adverse events per the requirements of the sponsor, regulatory bodies, and site policies.

Coordinates and gathers information from a variety of sources to ensure subject safety
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