Clinical Research Coordinator II

Clinical Trial Manager

Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.

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.

Job Description:

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