Clinical Research Coordinator II

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

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

ESSENTIAL FUNCTIONS:

• 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 consents 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

KNOWLEDGE, SKILLS & ABILITIES:

• 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

EDUCATION & EXPERIENCE:

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