Clinical Trial Coordinator – Regulatory
New
F
FortreaClinical research
Remote US; Source API remote eligibility restrictions: United StatesFull-TimeJunior
Salary65,000 - 75,000 USD per year
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Job Details
- Experience
- At least one year of experience in a related field; 1-2 years of clinical research is required.
- Required Skills
- Data management
Requirements
- Have at least one year of experience in a related field, such as medical, clinical, pharmaceutical, laboratory research, data analysis, data management, or technical writing.
- Have 1-2 years of clinical research experience.
- Have a university or college degree, preferably in life science, or certification in a related allied health profession from an accredited institution; relevant equivalent experience may be considered.
- Have a basic understanding of biology and biological processes.
- Be able to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines, and GCP.
- Demonstrate organizational and time-management skills.
- Have general computer literacy and the ability to use a variety of computer software.
- Work efficiently and effectively in a matrix environment.
- Be able to work varied hours as required.
Responsibilities
- Serve as a contact for project teams and investigative sites, and document site contacts in contact reports.
- Monitor site performance and implement action plans with the CRA for sites not meeting expectations.
- Assist CRAs with site-visit preparation, including running reports, checking files for missing documents, and resolving prior action items.
- Review Case Report Forms and generate and resolve queries under established data-review guidelines.
- Coordinate study visits and shipments of study drug, ancillary supplies, and laboratory kits or samples.
- Manage sites to support subject compliance with protocol requirements, study visits, and timelines.
- Distribute and track clinical trial supplies and ensure sites have sufficient supplies for recruitment.
- Work with sites and project teams to complete maintenance activities, including amendments and revised documents.
- Enter weekly details in CTMS or as required by the study.
- Assist with submissions and notifications to Ethics Committees and Regulatory Authorities.
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