Clinical Trial Specialist
2 days ago
Nashville
Job Description 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 401K 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 <10 years, • 6.77 hours per bi-weekly payroll; equivalent to 22 days if annualized, • 10 years and greater, • 7.69 hours per bi-weekly payroll; equivalent to 25 days if annualized PTO Pay:, • PTO is paid at the team member’s straight-time rate., • PTO is not part of any overtime calculation (i.e., it is not considered hours worked)., • For the purposes of PTO, a “day” is defined as the number of hours regularly scheduled to work. Team members may not submit PTO for more than the number of hours regularly scheduled in a day., • Accrued, but unused PTO balances are paid out upon termination or transfer to an ineligible position., • Upon termination of employment or transfer to an ineligible position, PTO will be paid out as follows: 100% of legacy vacation and carryover balances and up to 80 hours of current year's accrued but unused PTO balance. PTO Carryover:, • Up to 80 hours of unused PTO can be carried over each calendar year., • The maximum carry over balance is 240 hours. Scheduling PTO:, • Team members are required to use available PTO when taking time off from work and must have enough accrued PTO to cover the total absence up to a maximum negative of 40 hours. Remember, PTO taken but not yet accrued will be recouped at termination., • PTO is not required for approved military leave or when receiving other approved paid benefits such as disability pay, worker’s compensation, paid parental leave., • PTO may be taken in increments of as short as one hour., • Whenever possible, PTO must be scheduled in advance and is subject to supervisory approval, department staffing needs and established departmental procedures. Floating Holidays:, • The Practice may elect to substitute a floating holiday in place of one or more of its Practice-designated holidays., • Team members may not use a floating holiday within the first 30 days of hire. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.