This position works closely with the research team to help coordinate the approval processes and conduct of research protocols, assured that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, GHCR policies and procedures, and research protocols. The Clinical Trial Specialist I will assist in the management of subjects on clinical trials and coordinating activities associated with clinical trials under the mentorship and guidance of a Clinical Trial Specialist II.

ESSENTIAL FUNCTIONS:

• Manage and execute the day-to-day operations of complex Phase I-IV clinical research protocols in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, and regulatory affairs) in order to accurately coordinate clinical study activity.
• Provides second check for patient eligibility to clinical trial, following review by research nurse, including a second check of inclusion/exclusion requirements and eligibility criteria
• Attend and oversee Site Initiation Visits
• Coordinate and attend regular monitoring visits and closeout visits
• Maintains informed consents records of each patient for the duration of a study
• Maintains and files all relevant study documents throughout lifetime of a trial
• Provides regular and concise updates on study timelines, patient statuses, and trial details to study teams, Principal Investigator, and study sponsor.
• Meets data management deadlines set by internal and external teams
• Acts as a point of contact for Research Data Coordinator, and assists with and reviews data entry where necessary
• Protects the rights, safety, and welfare of patients
• Strives to maintain harmonious relationships with clinic personnel, clients, and administrative staff
• Reviews newly activated protocols, amendments, notices, suspensions, and terminations
• Maintains required certification in Good Clinical Practice and Good Documentation Practice
• Serves as a liaison to multiple Tennessee Oncology departments, providers, and other personnel
• Serves as a liaison between GHCR and external clients and sponsors
• 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
• Proactively identifies trial-related issues and provides recommendations for resolution
• Executes job responsibilities with the understanding of how output would affect, and impact other areas related to own job area/team with occasional guidance

KNOWLEDGE, SKILLS & ABILITIES:

• Ability to independently handle multiple priorities in a fast-paced environment
• Ability to comprehend complex clinical trial protocols
• Microsoft Office product knowledge (Word, Excel, PowerPoint, SharePoint and OneNote)

EDUCATION & EXPERIENCE:

• Bachelor’s Degree or equivalent combination of education and experience required
• One year of experience working in clinical trials required

About Tennessee Oncology

Established in 1976 by Dr. Stuart Spigel 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. To this day, our growing network of physicians and number of locations is based on this mission. In 2018, Tennessee Oncology joined OneOncology, a partnership of oncologists and industry leading experts driving the future of community-based cancer care in the United States, as a founding practice partner.

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