Clinical Research Coordinator II

OneOncology•Gallatin, TN

About The Position

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.

Requirements

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

Nice To Haves

Bilingual (English/Spanish) a plus

Responsibilities

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