Job Description

Clinical Trial Coordinator (Home-based)

The Clinical Trial Coordinator is responsible for independently managing multiple clinical trial sites from study start-up through closeout in a fully remote capacity. This role serves as the primary point of contact for each site, ensuring all essential documents are collected, reviewed, approved, and filed accurately to support rapid site activation and ongoing compliance. The coordinator guides site personnel through all aspects of study readiness, maintains real-time data in clinical systems, and oversees site performance across a high-volume portfolio. This is a fast-paced, high-visibility position suited for experienced professionals who are confident, proactive, and comfortable taking full ownership of their assigned sites.

Responsibilities

• Manage multiple clinical trial sites from study start-up through closeout, serving as the primary point of contact for each site.
• Guide site personnel through all aspects of study readiness, including addressing protocol questions, clarifying document requirements, and setting operational expectations.
• Collect, review, approve, and file all essential documents required for site activation and ongoing regulatory compliance.
• Maintain accurate, real-time updates in the Clinical Trial Management System (CTMS), including daily logs of site communications and status changes.
• Perform daily filing of study documents in the sponsor's Veeva Vault eTMF and complete scheduled quality control checks on the electronic trial master file.
• Handle logistics checks and query resolution for enrolled subjects in the absence of assigned Clinical Research Associates, ensuring data accuracy and protocol adherence.
• Provide timely and precise site status updates, actively managing activation timelines and study milestones across a high-volume site portfolio (potentially 20–30 sites on larger studies).
• Build and sustain strong site relationships, ensuring ongoing compliance, performance, and engagement throughout the study lifecycle.
• Work independently to anticipate site needs, identify issues early, and implement solutions that keep studies moving forward without prompting.
• Support fast-moving timelines and evolving study requirements, adapting quickly to new processes, expectations, and priorities.
• Communicate confidently and professionally with investigators, coordinators, and other site personnel, offering training and support as needed.
• Contribute to a collaborative, mission-driven research environment by sharing knowledge, supporting colleagues, and promoting transparency and inclusion.
• Participate in occasional travel for Investigator Meetings or Kickoff Meetings if required.
• Onboard quickly to active and new studies, learning study protocols and systems efficiently to begin contributing with minimal ramp-up time.

Essential Skills

• Minimum three years of clinical research and end-to-end clinical trial management experience, such as in-house CRA or similar roles.
• Demonstrated experience supporting clinical trials from start-up through closeout, including hands-on document and site management responsibilities.
• Clinical research organization (CRO) experience with the ability to operate independently from day one.
• Proven expertise in essential document management, including collection, review, approval, and filing from study start-up through site activation.
• Ability to provide accurate, timely site status updates and maintain activation timelines in a high-visibility environment.
• Strong attention to detail with the ability to work quickly while maintaining high quality standards.
• Strong verbal and written communication skills, with the confidence to guide, train, and support site personnel.
• Experience answering protocol questions, explaining document corrections, and proactively driving site progress.
• Ability to take full ownership of assigned sites from start-up through closeout and manage a high-volume workload of up to 20–30 sites, depending on the study.
• Hands-on experience with CTMS platforms for real-time updates, daily communication logs, and reporting.
• Daily use of eTMF systems, preferably Veeva Vault, including quarterly quality control checks.
• Experience performing logistics checks and query resolution for enrolled subjects.
• Demonstrated ability to keep pace with high document volume and daily processing expectations.
• Proactive, self-directed work style with a track record of anticipating needs and solving problems early.
• Ability to thrive in a fast-paced environment with tight timelines and high expectations.
• Comfort working fully remote with minimal oversight.
• Completed four-year degree.
• Ability to onboard quickly and adapt to evolving study needs.

Additional Skills & Qualifications

• Experience supporting studies that do not have dedicated CRA oversight, taking on broader site-facing responsibilities.
• Prior experience working on device, observational, or post-market clinical studies.
• 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.
• References that demonstrate reliability, initiative, and strong site-facing communication skills.
• Comfort working within a mission-driven, academic-oriented clinical research environment.
• Interest in contributing to high-impact clinical research that advances patient care and innovation.
• Ability to engage effectively in a collaborative culture that values transparency and inclusion.

Work Environment

This position is 100% remote, offering flexibility and the ability to work from your home office while supporting a high-volume portfolio of clinical trial sites. The role relies heavily on digital tools and systems, including CTMS platforms, Veeva Vault eTMF, and other sponsor-provided technologies for document management, communication logging, and reporting. Work is fast paced, with tight timelines and high expectations for responsiveness, accuracy, and proactive problem-solving. While travel is not routinely required, occasional trips for Investigator Meetings or Kickoff Meetings may be necessary. The culture emphasizes meaningful, mission-driven work, professional growth through training and mentorship, and a collaborative environment that values transparency, inclusion, and shared success. Candidates should be comfortable working independently with minimal oversight and engaging virtually with colleagues and site personnel across multiple time zones. For potential future conversion to a permanent role, candidates should reside in one of the following states: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Washington, D.C., or Wisconsin.

Job Type & Location

This is a Contract position based out of Philadelphia, PA.

Pay and Benefits

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. 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 Sep 24, 2026.

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