Clinical Research Coordinator II
2 weeks ago
Job Summary: The Clinical Research Coordinator, (CRC) is to screen, enroll and follow study subjects while ensuring protocol and regulatory compliance and close monitoring while subjects are in study.
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:
• Create source documentation
• Record data legibly, in real time on source documents
• Accurately record study medication inventory, medication dispensation, and patient compliance
• Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed
• Record protocol exemptions and deviations as appropriate with sponsor
• Maintain copies of patient-specific correspondence in source charts
• Assist regulatory personnel with completion of continuing/final review reports
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
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