Clinical Trial Coordinator

Position Overview

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients. Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

As a PPD Clinical Trial Coordinator, you will provide administrative and technical support to the Project Team. You will support audit readiness by ensuring files are reviewed on schedule as detailed in the organization's WPD and department guidance document.

At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award-winning training, and benefits focused on the health and well-being of our employees.

Summarized Purpose

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule as 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 the 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 the 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.

Qualifications

• Education: High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor's degree preferred.
• Experience: 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 a proven ability to handle multiple tasks efficiently and effectively.
  • Demonstrated ability to effectively analyze project-specific data.

Employment Details

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office
• Location Type: [Information not provided]
• Salary: [Information not provided]