FSP Clinical Trial Coordinator
New
L
LifelancerClinical research
Source API remote eligibility restrictions: United StatesFull-TimeEntry
Salary not disclosed
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Job Details
- Languages
- Good English language and grammar skills and proficient local language skills as needed
- Experience
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
- Required Skills
- Microsoft ExcelMS OfficePowerPoint
Requirements
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
- Bachelor's degree preferred.
- Previous experience comparable to 0 to 1 year.
- Ability to work in a team or independently as required.
- Good organizational skills, attention to detail, and ability to handle multiple tasks efficiently.
- Ability to analyze project-specific data and systems for accuracy and efficiency.
- Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.
- Proficient in MS Office, including Word, Excel, and PowerPoint, and able to learn clinical trial database systems.
- Ability to complete the organization's clinical training program.
- Effective oral and written communication, judgment, decision-making, and risk escalation skills.
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.
- Maintain clinical trial systems and databases, including Activate and eTMF, and process trial documents.
- Support site activation, feasibility activities, site selection, and regulatory submissions.
- Compile and distribute Investigator Site File and pharmacy binder materials and study supplies.
- Analyze study metrics and findings reports, and help resolve site documentation findings.
- Communicate with sites and project teams about site issues, risks, follow-up, and survey responses.
- Maintain study documentation, training records, system access, and vendor trackers.
- Train new personnel in processes and systems.
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