Clinical Trial Specialist 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 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.

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) 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 sponsors
• 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
• Taking on more complex and divergent clinical trial protocols
• Develops study tools to aid in onboarding and department process improvement
• Acts as a preceptor and resource to new colleagues
• Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.

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
• 2-3 years of experience working in clinical trials required