Job Description

🎯 What you'll do:

Study Coordination: 
• Coordinate and manage all aspects of clinical trials, including patient recruitment, screening, and enrollment. 
• Schedule and oversee patient visits, ensuring timely collection of data and samples in accordance with the study protocol. 
• Oversee site initiation, monitoring, closeout activities, and equipment calibration to ensure compliance with study protocols and regulations. 
• Maintain study documentation, including case report forms, consent forms, and other essential study records. 
• Review monitoring follow-up letters to ensure timely completion and resolution of identified issues. 
• Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs). 
• Manage the receipt, shipment, and storage of study drug and trial samples. 
• Ensure proper handling and storage of study materials, medications, and biological samples. 
• Generate invoices for study sponsors as applicable or assigned. 
 
Patient Interaction: 
• Serve as the main point of contact for participants, answering questions and providing information regarding study protocols, treatment options, and expected outcomes. 
• Ensure patients understand the study’s risks, benefits, and requirements by assisting in the informed consent process. 
• Monitor and document patient progress throughout the study, ensuring that their safety and well-being are maintained. 
 
Data Management: 
• Enter, maintain, and monitor study data in the clinical trial management system (CTMS) and other relevant databases. 
• Perform quality control checks to ensure the accuracy and completeness of data. 
• Collaborate with trial site staff, sponsor or CRO to resolve any discrepancies or issues with study data. 
 
Regulatory Compliance:  
• Stay current with federal and global regulations, including ICH-GCP and FDA guidelines, and ensure the study's adherence to applicable regulatory requirements, as well as sponsor-specific requirements. 
• Assist with the preparation and submission of study protocols, amendments, and regulatory documents to the Institutional Review Board (IRB). 
• Prepare site materials, including training materials, regulatory binders, manuals, and support documentation, ensuring alignment with regulatory guidelines and ethical standards. 
• Conduct training for study staff on regulatory requirements and ensure compliance with study protocols. 
• Maintain regulatory binders and drug accountability documents for each study. 
• Archive all documentation at the end of the study per Sponsor and FDA-required timelines. 
 
Study Team Collaboration: 
• Work closely with the Principal Investigator, Clinical Research Manager, and other research staff to ensure the study’s success. 
• Communicate with sponsor representatives, providing regular updates on study progress and patient enrollment. 
• Assist with study recruitment strategies and participate in outreach activities. 

🌟 Who you are:

Education: 
• Bachelor's degree in a related field (e.g., life sciences, nursing, healthcare); CCRC Certification, and/or Master’s degree preferred. 
• GCP, BLS, IATA, and CSSR Certifications (or willingness to acquire if hired). 
 
Experience: 
• 3+ years of experience in clinical research and industry environments. 2+ years of experience with independent trial management preferred. 
• Solid understanding of drug development processes, FDA, and ICH GCP guidelines. 
• Proficiency in using multiple software systems and computer technology (preference for experience with Florence, Advarra and Greenphire). 
 
Skills: 
• Strong organizational, leadership, and time-management skills. 
• Excellent written and verbal communication skills. 
• Ability to work independently and as part of a multidisciplinary team. 
• Experience working on collaborative, diverse, and feedback-driven teams. 
• Proven history of adapting and thriving through periods of change.