Are you looking to contribute to groundbreaking research? We look forward to having you join our team to collaborate on groundbreaking research!

The Clinical Research Coordinator II serves as the lead coordinator on an assigned portfolio of research studies, functioning independently to establish and coordinate logistics and processes for the conduct of research for the department.  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 applicable regulatory requirements.

• Establishes and completes 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 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.
• Responsible for screening and recruitment of potential patients for protocol eligibility, communicating non-medical trial concepts and details to the patients, and supporting the informed consent process.
• Responsible for accurate and timely data collection, documentation, entry and reporting, including timely response to sponsor queries.
• Coordinates institutional, pharmaceutical and internal audits, including facilitating third party study monitoring and designs and implements needed corrective actions.
• 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 routine 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.
• Provides technical support for the preparation of grant proposals, publications, presentations and special projects.
• Plans and coordinates strategies for growing research participant enrollment, and/or improving clinical research efficiency as needed.
• Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
• Provides assistance with research finance billing, including identifying and classifying routine care vs. research related care.
• Participates in meetings and conferences related to research activities, including research staff meetings.
• Participates in planning, workshops, evaluation meetings, and seminars, educational or administrative meetings as vital or requested.

Education

• Associates Degree/College Diploma - Minimum
• Bachelor's Degree - Preferred
• 3 years of clinical research coordination or related experience  - Required 
• BLS -  Preferred
• SoCRA or ACRP Certification - Preferred

Experience

• 3 Years Clinical research coordination or related experience