The basic purpose of the Project Assistant is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager. 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 skillsExcellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectivelyAbility to effectively analyze project specific data/systems to ensure accuracy and efficiencyFlexibility to reprioritize workload to meet changing project timelinesResponsible 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 closeoutExcellent English and grammar skillsExcellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systemsAbility to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)Ability to mentor and train new Project Assistants as neededPPD 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.

Additional Information

Requisition ID: 156867
Additional Information

Requisition ID: 156867