Clinical Trial Specialist

Clinical Trial Specialist The Clinical Trial Specialist supports the compliant, efficient execution of Phase I-IV oncology clinical trials by serving as the operational and regulatory lead for active protocols. This role oversees daily study operations, documentation integrity, and quality control for patient eligibility and protocol adherence. Working closely with investigators, sponsors/CROs, clinic teams, and internal research operations, the Clinical Trial Specialist focuses on protocol execution, regulatory oversight, data quality, and sponsor-facing trial management. Key Responsibilities Manage daily operations of active oncology clinical trials from activation through close-out Oversee live protocols, tracking timelines, milestones, and deliverables Ensure compliance with GCP/ICH guidelines, federal regulations, and sponsor requirements Maintain regulatory binders and electronic trial records; ensure inspection readiness Review protocol amendments, study communications, suspensions, and terminations Ensure informed consent documents are current, accurate, and properly filed Perform second-level patient eligibility review and verify inclusion/exclusion criteria prior to enrollment Attend and support site initiation, monitoring, and close-out visits Serve as a liaison between investigators, sponsors, CROs, and internal research, regulatory, and data teams Support data quality through review, timely data submission, and collaboration with data coordinators Provide clear updates on enrollment status, patient progress, and trial timelines Coordinate workflow and scheduling with clinic staff across multiple community sites Maintain patient confidentiality and uphold ethical research standard Support vendor coordination and regulatory documentation as needed Required Qualifications & Experience Bachelor's degree preferred At least 1 year of clinical trial experience

REQUIRED

Experience in operational, regulatory, data-focused, and sponsor-facing roles Familiarity with vendor management in clinical research settings Working knowledge of GCP/ICH guidelines and federal regulations Ability to interpret complex clinical trial protocols Proficiency in EDC,EMR and Microsoft Office Experience supporting multi-site or community-based research networks Oncology clinical trial experience preferred Job Type & Location This is a Permanent position based out of Nashville, TN. Pay and Benefits The pay range for this position is $58000.00 - $62000.00/yr. 401

K Retainment Plan:

Eligibility:

• Full-time employees are eligible to set up and contribute to the 401(K) plan once they have completed two months (60 days) of employment.
• Once you achieve eligibility, within 30 days, you will receive an email from Sentinel with instructions for setting up your account. The information will not come from Human Resources.
• The Sentinel site provides instructions for common transactions like rolling over funds from a prior 401k account.
• The access code for first-time set up is which will be listed in the materials you receive from Sentinel once you're eligible.
• The plan allows four types of contributions: salary deferrals including Roth 401k (e.

g. post-tax contributions); safe harbor; profit sharing; and rollover contributions from other accounts.

Safe Harbor Company Contribution:

will make a safe harbor contribution equal to 3% of your compensation. This contribution is 100% vested and employees are eligible after completing 60 days of employment. (See page 5 of 401k Summary Plan Description)

Profit Sharing:

may make a discretionary profit sharing contribution to your account. Plan participants become eligible for profit sharing after completing 12 months of employment. Profit Sharing Contributions vest over five years of service: Year One is 20%, Year Two is 40%, Year Three is 60%, Year Four is 80%, and Year 5 is 100%. (See 401k Summary Plan Description)

PTO:

PTO combines vacation, sick and personal leave. Team members are accountable and responsible for managing their own PTO hours to allow for adequate reserves if there is a need to cover vacation, illness or disability, appointments, emergencies, or other situations which require time off from work.

Eligibility:

PTO is accrued upon hire or transfer into a PTO-eligible position. Eligible team members must be scheduled to work at least 16 hours per week on a regular basis. Team members working less than 16 hours per week on a regular basis, PRN, and temporary team members are not eligible for PTO.

Accruals:

• PTO accruals are available for use in the pay period following completion of 30 days of employment.
• Team members may not have a negative PTO balance greater than forty (40) hours at any given time. Team members may carry over a negative balance.
• PTO taken but not yet accrued will be recouped at termination.
• PTO does not accrue while on a designated leave of absence or inactive status.

Accrual Rates:

• Length of service determines the rate at which the team member will accrue PTO. Team members become eligible for the higher accrual rate on the first day of the pay period in which the team member's anniversary date falls. Full-Time (30+ hours per week) These accrual rates apply to those hired after 1/1/2020.
• Years of Service
• Rate of Accrual
• Less than 5 years
• 5.23 hours per bi-weekly payroll; equivalent to 17 days if annualized
• 5 years to