CLINICAL RESEARCH COORDINATOR (PHASE i)

The Clinical Research Coordinator (CRC) primarily is responsible for integrating research with investigational new drugs and managing research operations within Phase I of research studies.

Required education, knowledge, skills and abilities: 

The position of CRC requires at least a Bachelor’s degree in one of the basic sciences or a related field.  The position of CRC requires good management and organizational skills, understanding of medical procedures, exceptional interpersonal skills, the ability to work independently and in a fast-paced Phase I environment, strong computer skills and writing ability. The CRC must be able to review and execute contracts with research participants. The CRC must meet course requirements for Good Clinical Practices (GCPs), infection control, handling of hazardous materials, basic cardiac life support (BCLS), and other specific study-related training.  Experience working in a Phase I unit a must. 

Responsibilities:

The activities of the CRC include, but are not limited to:

• Responsible for developing site documentation
• Development of source files and regulatory documents
• Processing of information received from pharmaceutical sponsors and clinical research organizations (CROs)
• Preparation of Institutional Review Board (IRB) submissions
• Conduct subject visits, including scheduling, delivery of oral and written informed consent, completion of subjects assessment(s), charting, collection of biological samples (e.g, blood, urine), medical testing (e.g., vital signs), and processing of data and samples collected during subject visits
• Completion of case report forms (CRFs), maintenance of source documents and CRF binders
• Completion of data clarification forms (DCFs) during and following completion of studies
• Storage of documents, as appropriate, in temporary and long-term storage in accordance with standard procedures
• Drug handling and storage
• Submission of regular reports to supervisor(s)
• Reading and understanding clinical research protocols, investigator's brochures, and other study-related materials
• Communication of pertinent information to other staff members who may be involved in research (e.g., physicians, laboratory technologists).  This includes the development of meetings or materials intended to serve as a resource for other staff
• Attendance at investigator meetings as needed, attendance at other meetings with study sponsors or their agents as needed
• Hosting site visits as needed
• Conducting all work in accordance with Good Clinical Practices (GCPs), Corporate Standard Operating Procedures (SOPs), and principles set forth in the CFR and ICH guidelines
• Maintenance of study regulatory documents, including screening and enrollment logs, drug accountability logs, subject identification logs, and site signature logs
• Communication with sponsors and CROs regarding pertinent issues (e.g., deviations and exemptions, enrollment statistics)
• Other duties as assigned

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