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The Clinical Research Coordinator I supports clinical research protocols for the department. The Clinical Research Coordinator will assist the Research Department with all aspects of clinical research. This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research protocols, in compliance with all regulatory requirements.

Primary Duties and Responsibilities:

• Responsible for administrative functions of research studies, including scheduling of patients for research visits, procedures and labs and completion and maintenance of consent forms, case report forms, SAE’s and source documents.
• Facilitates screening and recruitment of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and supporting the informed consent process.
• Coordinates logistical aspects of clinical research projects to achieve project objectives, including project planning, projecting resource requirements, and developing systems to ensure protocol compliance and patient safety.
• Responsible for accurate and timely data collection, documentation, entry and reporting, including timely response to sponsor queries.
• Schedules and participates in monitoring and auditing activities to ensure compliance, including implementing any corrective actions.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• Works closely with investigators and regulatory staff or directly with Institutional Review Board (IRB) to submit adverse events, serious adverse events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Acts as a liaison with pharmaceutical company representatives or other project funding organizations to monitor and update project progress.
• Provides assistance with research finance billing, including identifying and classifying routine care vs. research related care.
• Attends meetings and conferences related to research activities, including research staff meetings.
• Participates in planning, workshops, evaluation meetings, seminars, educational or administrative meetings as necessary or requested.

Education:

• High School Diploma/GED is required. An Associate Degree/College Diploma is preferred.

Licenses and Certifications:

• Basic Life Support (BLS) is required.
• Certification in clinical research (SoCRA or ACRP certification) is preferred.

Experience and Skills:

• Six (6) months of healthcare-related or research experience is required. One (1) year of clinical research coordination is preferred.
• Maintains comprehensive knowledge of assigned research protocols to coordinate the compliant execution of assigned tasks in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.
• Ability to use software applications (MS Office Suite - Excel, Word, Outlook, PowerPoint) and operate technological devices (e.g., computer, laptop, tablet, smartphone, etc.).
• Establishes effective working relationships with cross-functional team(s).
• Identifies and responds appropriately to both internal and external customer needs utilizing available resources.
• Responds timely, effectively,y and appropriately to deliverables.
• Cultivates and maintains strong customer relationships and rapport with stakeholders and/or client groups.