Clinical Trial Coordinator - Customer Dedicated (FSP)
PPD
TW Taipei FSP Taipei TW Zhong Xiao W.Rd
3天前

Summarized Purpose :

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.

Essential Functions :

  • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
  • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
  • Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
  • Supports the maintenance of study specific documentation and systems including but not limited to : study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
  • Provides system support (i.e. GoBalto & eTMF).
  • Supports RBM activities.
  • Performs administrative tasks on assigned trials including but not limited to : timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Supports scheduling of client and / or internal meetings.
  • Reviews and tracks local regulatory documents.
  • Transmits documents to client and centralized IRB / IEC.
  • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
  • Maintains vendor trackers.
  • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assists with study-specific translation materials and translation QC upon request.
  • Job Qualification

    Education and Experience :

  • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
  • Bachelor's degree preferred.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
  • In some cases an equivalency, consisting of a combination of appropriate education, training and / or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Knowledge, Skills and Abilities :

  • Ability to work in a team or independently as required
  • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
  • Demonstrated ability to effectively analyze project-specific data / systems to ensure accuracy and efficiency
  • Strong customer focus
  • Flexibility to reprioritize workload to meet changing project timelines
  • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization / Client SOPs and WPDs for all non-clinical / clinical aspects of project implementation, execution and closeout
  • Good English language and grammar skills and proficient local language skills as needed
  • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
  • Ability to successfully complete PPD clinical training program
  • Self-motivated, positive attitude and good interpersonal skills
  • Working Environment :

    PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

    Below is listed the working environment / requirements for this role :

  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary for typical working hours.
  • Ability to use and learn standard office equipment and technology with proficiency.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
  • May require travel. (Recruiter will provide more details.)
  • PPD® FSP : People Who Deliver PPD Careers - Read about PPD employee experiences!

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