Job Summary:

Duties Include:

• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• Obtain informed consent
• Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol
• Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
• Review laboratory results, ECGs, and other test results (e.g., MRI and Biopsy reports) for completeness and alert values, ensure investigator review in a timely fashion
• Recognize Adverse Events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator
• Schedule patients within visit windows
• Dispense study medication per protocol and or IVRS system; educate subject on proper administration and importance of compliance
• Monitor subject progress on study medication

Documentation:

Knowledge, Skills, and Abilities:

• Excellent working knowledge of medical and research terminology
• Extensive working knowledge of federal regulations, Good Clinical Practices (GCP)
• Ability to communicate and work effectively with a diverse team of professionals
• Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word and Excel
• Excellent interpersonal skills, detailed-oriented and meticulous
• Ability to work independently in a fast-paced environment with minimal supervision

Experience:

• Four years of Clinical Research Coordinator experience

License/Certification:

• GCP
• Research Professional Certificate – CCRC or exam eligibility preferred