Clinical Trial Coordinator (Homebased)
This fully remote Clinical Trial Coordinator role manages multiple clinical trial sites from study start-up through closeout, serving as the primary point of contact for each site. You will lead site readiness activities, oversee essential document management, and maintain real-time study oversight using CTMS and Veeva Vault eTMF. With no CRAs assigned, you will own site relationships end-to-end, ensuring compliance, performance, and timely activation across a high-volume site portfolio. This contract position suits an experienced, confident coordinator who thrives in a fast-paced, mission-driven clinical research environment and can onboard quickly to support active and upcoming studies.
Responsibilities
- Serve as the primary point of contact for assigned clinical trial sites from study start-up through closeout.
- Manage multiple clinical trial sites simultaneously, including high-volume portfolios of approximately 20–30 sites on larger studies.
- Guide site personnel through all aspects of study readiness, including protocol interpretation, document completion, and operational expectations.
- Collect, review, approve, and file essential regulatory and study documents to support rapid site activation.
- Maintain accurate, real-time site status updates in the Clinical Trial Management System (CTMS).
- Log daily site communications and interactions in CTMS to ensure complete and current documentation of site activities.
- Perform daily filing of essential documents in the sponsor’s Veeva Vault electronic Trial Master File (eTMF).
- Conduct regular quality control checks (including quarterly QC) on eTMF filings to ensure accuracy, completeness, and compliance.
- Perform logistics checks and manage query resolution for enrolled subjects in the absence of CRA oversight.
- Monitor site performance and compliance throughout the study lifecycle and proactively address issues or delays.
- Answer protocol-related questions from site personnel and provide clear guidance on document corrections and study procedures.
- Drive site progress proactively by anticipating needs, resolving issues early, and keeping sites on track with activation and study timelines.
- Provide timely and accurate status updates on site activation, enrollment, and document completion to stakeholders.
- Work independently with minimal oversight, taking full ownership of assigned sites and responsibilities.
- Collaborate with internal team members to support high-impact clinical research projects and ensure consistent study execution.
- Adapt quickly to evolving study needs, timelines, and priorities in a fast-paced environment.
- Support occasional travel to Investigator Meetings or Kickoff Meetings if required.
- Contribute to a collaborative, transparent, and supportive team culture by sharing knowledge and assisting colleagues as needed.
Requirements
- Minimum 3 years of clinical research experience with end-to-end trial management from start-up through closeout.
- Background in regulatory, study start-up, or site-level coordination with significant document management responsibilities.
- Proven experience collecting, reviewing, approving, and filing essential documents to support site activation.
- Demonstrated ability to provide accurate and timely site status updates and maintain activation timelines.
- Strong knowledge of clinical research processes, regulatory compliance, and site management.
- Experience managing a high volume of sites independently, including portfolios of up to 20–30 sites.
- Strong verbal and written communication skills, with confidence in guiding and training site personnel.
- Ability to answer protocol questions and clearly explain document corrections and operational expectations.
- Hands-on experience with Clinical Trial Management Systems (CTMS) for real-time updates, conversation logging, and reporting.
- Experience with electronic Trial Master File (eTMF) systems, preferably Veeva Vault, including daily filing and periodic quality checks.
- Experience performing logistics checks and managing query resolution for enrolled subjects.
- Proven ability to work effectively in a fast-paced, high-visibility environment with tight timelines.
- Demonstrated capacity to work independently, operate with minimal oversight, and take full ownership of assigned responsibilities.
- Ability to onboard quickly and adapt to evolving study needs and priorities.
- Only experienced candidates at a CTC II or CTC III level who can operate independently from day one will be considered.
Skills
- Experience supporting studies without dedicated CRA oversight.
- Prior experience with device, observational, or post-market clinical studies.
- Ideal backgrounds include Regulatory Specialist, Start-Up Specialist, or experienced Clinical Research Coordinator roles with hands-on document and site management responsibilities.
- Strong organizational skills with the ability to multitask, prioritize, and manage competing deadlines.
- Positive, team-oriented attitude with a willingness to support colleagues and contribute to shared success.
- Proactive, self-directed workstyle with a “go-getter” mindset, anticipating needs and solving problems early.
- Comfort working in a fully remote environment while maintaining high productivity and accountability.
- References that demonstrate reliability, initiative, and strong site-facing communication skills.
- Interest in contributing to mission-driven clinical research that advances patient care.
- Motivation to leverage training opportunities, mentorship, and exposure to diverse therapeutic areas for professional growth.
Work Environment
This role is 100% remote, offering flexibility in location and time zone while requiring support for fast-moving timelines and high-volume site portfolios. You will work in a fully virtual environment using CTMS platforms for real-time site tracking and communication logging, and Veeva Vault eTMF for daily document filing and periodic quality checks. The position involves managing complex, high-visibility studies without CRA oversight, so you will operate with significant autonomy and responsibility. While travel is not routinely expected, occasional travel to Investigator Meetings or Kickoff Meetings may be required. You will collaborate with a mission-driven, supportive team that values transparency, inclusion, and shared success, and you will have opportunities to engage in meaningful clinical research projects, access training resources, and benefit from a flexible contract arrangement that supports work–life balance.
This is a Contract position based out of Overland Park, KS.
Pay
The pay range for this position is $40.00 - $46.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits
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)