Clinical Trial Coordinator- Homebased

Clinical Trial Coordinator (Remote)

This fully remote Clinical Trial Coordinator role manages multiple clinical trial sites from study start-up through closeout and serves as the primary point of contact for each site. You will own all aspects of site readiness, essential document management, and ongoing site performance in a fast-paced, high-visibility environment. With no CRAs assigned to these studies, you will independently oversee site relationships, ensure regulatory compliance, and support rapid site activation across a high-volume portfolio. This opportunity is ideal for an experienced CTC II or III who thrives in a dynamic setting, takes full ownership of their work, and is motivated by contributing to impactful clinical research.

Responsibilities

• Manage multiple clinical trial sites from study start-up through closeout, serving as the primary point of contact for each site.
• Lead site readiness activities, including addressing protocol questions, guiding document corrections, and setting clear operational expectations.
• Collect, review, approve, and file all essential documents from start-up through site activation, ensuring accuracy and completeness.
• Maintain real-time status updates in the Clinical Trial Management System (CTMS), including daily site communication logs and reporting.
• Perform daily filing of study documents in the sponsor's Veeva Vault eTMF and conduct quarterly quality control checks.
• Handle logistics checks and query resolution for enrolled subjects, assuming responsibilities typically handled by CRAs.
• Provide timely and accurate site status updates to support rapid activation and adherence to activation timelines.
• Drive site progress proactively by following up on outstanding items, resolving issues early, and removing barriers to activation.
• Own a high-volume portfolio of sites (potentially 20–30 sites on larger studies) and ensure consistent performance and compliance across all locations.
• Guide, train, and support site personnel to ensure understanding of study requirements, documentation standards, and operational processes.
• Monitor ongoing site compliance with study protocols, regulatory requirements, and sponsor expectations throughout the study lifecycle.
• Work independently with minimal oversight, prioritizing tasks effectively to meet tight timelines and high expectations.
• Collaborate with cross-functional teams to support study objectives, share updates, and align on timelines and deliverables.
• Participate in Investigator Meetings or Kickoff Meetings as needed, which may require occasional travel.
• Maintain high standards of documentation quality, organization, and audit readiness in all systems and filing processes.

Essential Skills

• Minimum 3 years of clinical research experience with end-to-end, multi-site trial management, preferably within a Contract Research Organization (CRO).
• Proven experience managing clinical trials from start-up through closeout, including hands-on document and site management responsibilities.
• Demonstrated expertise in essential document collection, review, approval, and filing for site activation.
• Experience supporting multiple sites simultaneously, with responsibility for 15 or more sites and the ability to scale up to 20–30 sites depending on study needs.
• Strong understanding of essential regulatory document processes and regulatory compliance requirements.
• Varied therapeutic area experience in clinical research.
• Ability to operate independently from day one, with no need for entry-level training or close supervision.
• Strong, confident communication skills, including the ability to explain protocol requirements, document corrections, and operational expectations clearly and succinctly.
• Proficiency with Clinical Trial Management Systems (CTMS) for real-time updates, daily conversation logs, and reporting.
• Experience with electronic Trial Master File (eTMF) systems, including daily filing and organization; specific experience with Veeva Vault eTMF is highly relevant.
• Experience performing logistics checks and query resolution for enrolled subjects in the absence of assigned CRAs.
• Exceptional attention to detail and the ability to work quickly without sacrificing quality.
• Demonstrated ability to thrive in a fast-paced environment with tight timelines and high expectations.
• Proactive, self-directed work style with a strong sense of ownership and accountability for assigned sites.
• Clear, concise written and verbal communication skills for effective collaboration with site personnel and internal stakeholders.

Additional Skills & Qualifications

• Background as a Regulatory Specialist, Start-Up Specialist, or experienced Clinical Research Coordinator with significant document and site management responsibilities.
• Experience working in site, CRO, or pharmaceutical environments, with flexibility regarding specific setting as long as end-to-end trial management experience is present.
• Comfort managing high-visibility work where accuracy, timeliness, and organization are critical.
• Ability to anticipate issues, solve problems early, and keep sites moving forward without prompting.
• Willingness to go the extra mile to support team members and overall study success.
• Comfort working in a fully remote setting with minimal oversight while maintaining high productivity.
• Strong organizational skills for managing high document volume and daily processing expectations.
• Openness to occasional travel for Investigator Meetings or Kickoff Meetings when required.
• Interest in contributing to mission-driven clinical research that advances patient care.
• Motivation to engage in professional growth through exposure to diverse therapeutic areas and complex studies.

Work Environment

This role operates in a 100% remote work environment, offering flexibility in location and time zone while requiring consistent support for fast-moving timelines and high-volume site portfolios. You will work primarily with digital tools, including CTMS platforms for real-time tracking and reporting, and the sponsor's Veeva Vault eTMF for daily document filing and quarterly quality control checks. The position involves managing a large number of sites simultaneously, often 20–30 on larger studies, in a fast-paced, high-visibility setting where expectations for accuracy, responsiveness, and proactive problem-solving are high. Oversight is minimal, so you will work independently, organize your own schedule, and prioritize tasks to meet tight deadlines. Travel is not expected as part of day-to-day responsibilities, but you may occasionally attend Investigator Meetings or Kickoff Meetings as needed. The culture emphasizes collaboration, transparency, inclusion, and shared success, with opportunities to contribute to meaningful clinical research and to grow professionally through exposure to diverse therapeutic areas.

Job Type & Location

This is a Contract position based out of Raleigh, NC.

Pay and Benefits

The pay range for this position is $40.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jun 30, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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