Clinical Trial Coordinator – Regulatory
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Job Description
Clinical Trial Coordinator supporting Fortrea’s clinical research programs through regulatory site coordination, data review, submissions, and trial-supply tracking. Remote US role.
Responsibilities:
- Serve as contact for the project team and investigative sites
- Conduct and document site contacts for assigned sites according to study guidelines, including creating contact reports for telephone sessions
- Monitor site performance and implement action plans with the CRA for sites not meeting expectations
- Assist CRAs with site visit preparation by running reports, quality-checking files, and resolving prior action items
- Perform Case Report Form review, query generation, and query resolution under supervision on Fortrea or client data management systems
- Assist with coordinating study visits and shipment of drug, ancillary supplies, and laboratory kits/samples
- Manage sites to ensure subject compliance with protocol requirements, study visits, and timelines
- Distribute and track clinical trial supplies and ensure sites have sufficient supplies for recruitment
- Coordinate maintenance activities, including amendments and revised documents, for assigned sites
- Enter weekly study details in CTMS as required
- Assist with submissions and notifications to Ethics Committees and Regulatory Authorities
- Facilitate translation and back translation of required documents for local country requirements
- Attend and present at investigator, sponsor, kick-off, and face-to-face meetings as needed
Requirements:
- At least one year of experience in a related field, (e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing)
- 1-2 years of clinical research is required
- Basic understanding of biology and biological processes
- Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
- Good organizational and time management skills
- Good communication skills, oral and written
- General computer literacy
- Ability to work efficiently and effectively in a matrix environment
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Light to moderate lifting and carrying objects including luggage and laptop computer with a maximum lift of 15-20 lbs
- Regular and consistent attendance
- Varied hours may be required
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