PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD’s Clinical Management department is committed to industry leadership and the relentless pursuit of excellence. Working in the Clinical Management department, you will combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market.
As a Project Assistant, you will provide technical and administrative support to your assigned clinical project team. You work with a high attention to detail, reviewing documentation, coordinating project details, and maintaining data systems - all with a sense of urgency aligned with that of our customers.
Grow within the Clinical Management department into senior-level Project Assistant roles or leadership roles within the department.
Or, develop into Remote Site Monitor or Clinical Research Associate roles. You can also explore opportunities within other groups, such as Site and Patient Access.
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
At PPD wehire the best, develop ourselves and each other, and recognize the power of beingone team. It's not just talk - our award winning training programs speak forthemselves.
To learn how PPD can advance your career, apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
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
PPD values thehealth and wellbeing of our employees. We support and encourage individuals tocreate a healthy and balanced environment where they can thrive.
Below is listed the workingenvironment / 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)