FSP Clinical Trial Coordinator II
New
United States, Eastern Standard TimeFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 1-2 years
- Required Skills
- Microsoft ExcelMS OfficePowerPoint
Requirements
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Bachelor's degree preferred with education in medical or biological sciences or discipline associated with clinical research preferred
- 1-2 years of previous experience that provides the knowledge, skills, and abilities to perform the job
- Ability to work in a team or independently
- Strong organizational skills and attention to detail
- Proven ability to handle multiple tasks efficiently and effectively
- Proven ability to effectively analyze project-specific data/systems
- Strong customer focus
- Demonstrated flexibility and adaptability to reprioritize workload
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs
- Excellent English language and grammar skills and proficient local language skills
- Good presentation skills
- Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint)
- Ability to obtain knowledge and master all clinical trial database systems
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude with effective strong interpersonal skills
Responsibilities
- Coordinate, oversee, and complete assigned trial activities detailed on the task matrix.
- Perform department, internal, country, and investigator file reviews and document findings.
- Ensure allocated tasks are performed on time, within budget, and to a high quality standard, communicating any risks.
- Support the maintenance of study-specific documentation and global support with specific systems, tools, and trackers.
- Ensure (e)TMF is up to date by following file review schedules and document findings.
- Provide system support (i.e. GoBalto & eTMF) and support RBM activities.
- Perform administrative tasks including timely processing of documents, eTMF reviews, mass mailings, and communications.
- Support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
- Review and track local regulatory documents; transmit documents to client and centralized IRB/IEC.
- Analyze and reconcile study metrics and findings reports, assisting with clarification and resolution.
- Maintain vendor trackers.
- Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assist with study-specific translation materials and translation QC upon request.
- May attend Kick off meeting and take notes when required.
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