Sr Clinical Trial Coordinator

POSITION SUMMARY: 

Manage daily trial activities, including trial and provider outreach and referral coordination, providing trial support engagement and physician education, supporting monitoring site testing activity, referral coordination, physician education, and trial site engagement. Partner with the Clinical Project Manager to ensure effective trial management and maintenance of trial master forms and all relevant trial documentation. Ensure adherence to regulatory standards, as it relates to the scope of services.   

PRIMARY RESPONSIBILITIES:

Trial Compliance: Regulatory Adherence: Ensure all trial activities comply with current Good Clinical Practice (GCP) guidelines, Institutional Review Board (IRB) requirements, and other relevant regulatory bodies (e.g., FDA) by providing guidance to senior leadership..

• Trial Management
• Protocol Implementation: Exhibit deep understanding and familiarity of protocols, ensuring all procedures and requirements are followed by Natera by translating trial/protocol requirements and coordinating all cross-team activities, including patient outreach and enrollment. 
• Documentation Control: Maintain accurate, complete, and up-to-date trial master files (TMF), study binders, and all other site and trial forms. 
• Ensure sponsor and trial deadlines are met, manage study and sponsor accountability to milestones.
• Conduct enrollment activities, outreach, relevant trial follow-up, and managing study-related inquiries.

Data and Quality Assurance

• Quality Control: Perform internal quality checks all relevant trial documentation and data to prepare for site and PO reporting and monitoring updates, audits.
• Reporting: Generate and disseminate status reports on enrollment, adverse events, and protocol deviations to the Principal Investigator and sponsor.

Technical Adaptability: Engage with software engineers, data management specialists, and IT staff to deploy virtual and digital trial site activity, and the creation and maintenance of electronic data capture (EDC) systems or reporting and tracking tools.Communication and Reporting

• Analytical Support: directly own meeting patient enrollment rates and identify strategies for improving enrollment rates. Along with creating and maintaining reports that track trial activities, including site participation and testing, site enrollment and patient volumes, and engagement scores.
• Communication and Engagement: Support the development of strategies to help PIs proactively engage providers, facilitate enrollment activities, triage and drive to resolutions sponsor and site queries and feedback.  
• Conferences and Certifications: Maintenance of all relevant clinical or technical licensures. Attend conferences relevant to role and clinical field. 
• New Hire Onboarding/Training: Support staff recruitment and onboarding.
• Other duties and responsibilities to be performed as assigned 

QUALIFICATIONS: 

• Clinical Background: U. S. licensed Nurse, PA-C, NP, or DNP is required with a Master’s degree in health sciences. Strong understanding of medical terminology, disease processes (especially cancer), standard clinical workflows, and genetic testing.
• Clinical Trial Experience: Minimum of 4-5 years of experience as a clinical trial coordinator, preferably in cancer. 
• Data Management Expertise: Direct experience in managing study binders, trial master files, supporting study start-up and close, tracking study metrics, and identifying, screening, recruiting, and enrolling study subjects. 
• Quality and Compliance: Demonstrated commitment to data integrity, quality control processes, and adherence to HIPAA and other data privacy regulations. 
• Technical Proficiency: Proficient with Microsoft Office Suite or Google Suite, creating pivot tables, generating reports, data analysis, and using clinical data systems or databases common in clinical data abstraction, research, or clinical data management (e.g., fillable forms, ECDs, data registries). 
• Certifications/Industry Expertise: Must be a certified clinical research coordinator (CCRC) or in the process of obtaining certification. Deep knowledge of and experience working in remote and decentralized clinical trials. 
• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with PIs, sponsors, patients, and non-clinical teams.
• Autonomy: Proven ability to work independently, manage time effectively, prioritize and organize tasks, and meet strict productivity and quality deadlines.

General Expertise:

• Possess a high level of initiative and self-motivation.
• Capable of working part of a team on high visibility projects and tasks with high rates of communication. 
• In-depth attention to detail and a fast learner. 
• Responding to shifting priorities and changes.