FSP Clinical Trial Coordinator II
New
L
LifelancerClinical research
Remote, North Carolina, USAFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Excellent English language and grammar skills; proficient local language skills as needed.
- Experience
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
- Required Skills
- Microsoft ExcelMS Office
Requirements
- Hold a high school or secondary school diploma or equivalent and a relevant formal academic or vocational qualification.
- A bachelor's degree is preferred.
- Have comparable previous experience of at least 2 years.
- Maintain working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization and client SOPs.
- Demonstrate strong organizational skills, attention to detail, and the ability to manage multiple tasks.
- Analyze project-specific data and systems to support accuracy and efficiency.
- Be proficient in MS Office, including Word, Excel, and PowerPoint, and able to learn clinical trial database systems.
- Have English language and grammar skills, with local language proficiency as needed.
- Communicate effectively in writing and verbally, including with medical personnel.
- Work independently or as part of a team in a matrix environment and adapt to changing priorities.
- Complete the organization's clinical training program.
Responsibilities
- Coordinate, oversee, and complete assigned trial activities according to the task matrix.
- Review department, internal, country, investigator, and eTMF files, and document findings in the appropriate systems.
- Process trial documents, distribute communications, and provide documents and reports to internal team members.
- Track local regulatory documents, study metrics, findings, and vendor information.
- Support site activation, regulatory submissions, feasibility activities, and site-list development.
- Assist with compiling and distributing Investigator Site File and pharmacy binder materials and study supplies.
- Maintain accurate trial status, site contact, and investigator information in company systems.
- Communicate project risks and site issues to project leads, managers, and clinical personnel.
- Train new personnel and support onboarding and process improvement initiatives.
- Coordinate with internal departments and client teams to support project and site start-up activities.
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