RN-Clinical Research Coordinator (CRC)

Growing Midtown Manhattan Pharma company has an immediate need for a Temp-to-perm position as a Clinical Research Coordinator. Knowledge of Phase I clinical trials are a must. The Clinical Research Coordinator is primarily responsible for coordinating research with investigational new drugs and managing research operations. 

• Processing of information received from pharmaceutical sponsors and clinical research organizations (CROs) 
• Preparation of Institutional Review Board (IRB) submissions 
• Development of source files and regulatory documents 
• 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. 
• Subject recruitment and screening, which includes the development and placement of advertisements designed to attract subjects. 
• Subject database management. 
• 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 regulator documents, including screening and enrollment logs, drug accountability logs, subject identification logs, site signature logs. 
• Communication with sponsors and CROs regarding pertinent issues (e.g. deviations and exemption, enrollment statistics). 
• Basic regulatory document preparation, assisting the Site Manager and Director of Research. 
• Other duties as assigned.

Requirements: 

The position of CRC requires at least two years of experience coordinating Phase I clinical trials, exceptional clerical skills, good interpersonal skills, good computer skills, and good writing ability.  The CRC must also be licensed in New York State as a Physician’s Assistant OR Registered Nurse and 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.   

Call today to find out more about this great opportunity.

Please email resumes to info_hctemp@greenkeyllc.com and visit us at www.greenkeytemp.com