Clin Trial Assist Gicors Be

**JOB DESCRIPTION**:

- 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 life-saving 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 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 wellbeing of our employees.
- 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.

Qualifications - External
- 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 unde