Project Assistant

Responsibilities include, but are not limited to:
 

• Reviews regulatory documents for proper content
• Performs PPD investigator file reviews and logging of outstanding issues in project related tracking tools
• Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departments
• Assists with the identification of potential investigators and development/distribution of initial protocol packets
• Creates meeting agendas and minutes

Coordinates team conference calls and distribution of meeting minutes

Education and Experience:
 

• Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities

Knowledge, Skills and Abilities:
 

• Excellent communication and interpersonal skills
• Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
• Flexibility to reprioritize workload to meet changing project timelines
• Responsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
• Excellent English and grammar skills
• Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)
• Ability to mentor and train new Project Assistants as needed

If you are interested in this opportunity, submit your CV in English. This is an ongoing search and only shortlisted candidates will be contacted.

PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.

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