Clinical Research Coordinator II

Job Description

This position is responsible for the management of subjects on clinical trials and coordinating activities associated with clinical trials.

• Screens potential subjects for clinical trials through a careful review of the patient’s past medical history and a review of current findings against inclusion and exclusion criteria specific to a trial
• maintains informed consent records of each patient for the duration of a study
• Coordinates all patient visits including testing and procedures as per sponsor protocol
• Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and Tennessee Oncology databases while complying with sponsor protocol requirements, regulations, and department policies
• Assists regulatory staff in the maintenance of regulatory documents in accordance with department policies and regulations
• Liaises with sponsor staff such as study monitors
• Procures, processes, and ships biospecimens per sponsor protocol and regulations
• Protects the rights, safety, and welfare of patients
• Strives to maintain harmonious relationships with clinic team member, administrative staff, patients, their caregivers, and the public
• Reviews newly activated protocols, amendments, notices, suspensions, and terminations
• Responsible for maintaining current knowledge of the Code of Federal Regulations and International Council for Harmonization Guidelines
• Maintains required certification in Good Clinical Practice, Human Subjects Protections, and biological shipping training
• Serves as a liaison to multiple Tennessee Oncology departments, providers, and other team members regarding research protocols and regulatory compliance
• Maintains a professional approach respecting the dignity and confidentiality of patients
• Maintains a good attendance record and reports to work on time
• Maintains a professional attitude and appearance
• Maintain licensure as applicable
• Performs other duties as assigned

• Excellent verbal and written communication skills
• Excellent organization and follow-up skills
• Ability to handle multiple priorities in a fast-paced environment
• Ability to understand complex clinical trials protocols
• Ability to function in multi-functional teams
• Microsoft Office product knowledge (Word, Excel, PowerPoint, etc.)
• Bilingual (English/Spanish) a plus

• Bachelor’s Degree or equivalent combination of education and experience required
• Two years of relevant experience required