Clinical Trial Specialist

Tennessee Oncology • Nashville, TN

388d

About The Position

The Clinical Trial Specialist position at Tennessee Oncology involves coordinating the approval processes and conducting research protocols for clinical trials. The role is essential in ensuring the integrity and quality of research is maintained in compliance with Good Clinical Practice Guidelines and regulatory requirements. The specialist will manage day-to-day operations of clinical research protocols and support the research team in various capacities, including patient management and data coordination.

Requirements

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

Nice To Haves

• 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).

Responsibilities

• 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 to accurately coordinate clinical study activity.
• Provide second check for patient eligibility to clinical trial, 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.
• Maintain informed consents records of each patient for the duration of a study.
• Maintain and file all relevant study documents throughout the lifetime of a trial.
• Provide regular and concise updates on study timelines, patient statuses, and trial details to study teams, Principal Investigator, and study sponsor.
• Meet data management deadlines set by internal and external teams.
• Act as a point of contact for Research Data Coordinator, and assist with and review data entry where necessary.
• Protect the rights, safety, and welfare of patients.
• Strive to maintain harmonious relationships with clinic personnel, clients, and administrative staff.
• Review newly activated protocols, amendments, notices, suspensions, and terminations.
• Maintain required certification in Good Clinical Practice and Good Documentation Practice.
• Serve as a liaison to multiple Tennessee Oncology departments, providers, and other personnel.
• Serve as a liaison between GHCR and external clients and sponsors.
• Maintain a professional approach respecting the dignity and confidentiality of patients.
• Maintain a good attendance record and report to work on time.
• Maintain a professional attitude and appearance.
• Proactively identify trial-related issues and provide recommendations for resolution.

What This Job Offers

• Job Type: Full-time
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree