Project Assistant

Thermo Fisher Scientific•Las Vegas, NV

About The Position

As part of PPD’s clinical research team, the Project Assistant provides administrative and technical support to the project team, including planning, organizing, and coordinating project administration. The role maintains procedures, guidelines, documentation, and project records, and ensures regulatory documents are correct, processed, and approved. It also involves data entry and maintenance of database repositories, as well as preparing reports and collecting data for analysis. The Project Assistant supports document and file coordination, regulatory and study-specific documentation, communications, vendor tracking, local payments, meeting coordination, and project-management activities. The role maintains working knowledge of applicable GCPs, organizational and client SOPs, and protocol-specific requirements, and serves as a resource to the project team. Work is performed in an office or clinical environment, with exposure to electrical office equipment. Occasional drives to site locations and occasional travel may be required. The work includes frequent periods of stationary activity, repetitive hand movements, occasional mobility and bending, and occasional light lifting. The position requires regular attendance, the ability to handle changing demands and multiple tasks, and periods of intense concentration.

Requirements

High school/secondary school diploma or equivalent and a relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 2 years.
Self-motivation, a positive attitude, and effective oral, written, and interpersonal communication skills.
Ability to work independently or as part of a team, as required.
Good organizational skills, strong attention to detail, and demonstrated ability to handle multiple tasks efficiently and effectively.
Ability to analyze and update project-specific data and systems to ensure accuracy and efficiency.
Flexibility and adaptability to reprioritize workload and support changing project timelines.
Strong customer focus.
Ability to attain and maintain working knowledge of applicable regulations and procedural documents for project implementation, execution, and closeout.
Good English language and grammar skills.
Good computer skills, proficiency in MS Office, and ability to learn database systems and modern technology.
Good critical-thinking skills, including investigation for root-cause analysis and problem-solving.
Ability to work under constant pressure to meet project and client deliverables and timelines.
Ability to successfully complete required training programs, as applicable.
Ability to communicate information and ideas clearly and understand information presented verbally.
Ability to work with guidance or oral or written instructions from management, handle sensitive information, and interact with diverse groups.
Ability to perform variable tasks under changing conditions, manage multiple tasks, and perform under stress.
Regular and consistent attendance.

Responsibilities

Provide administrative and technical support to the project team, including planning, organizing, and coordinating project administration.
Maintain procedures, guidelines, documentation, and project records, and ensure regulatory documents are correct, processed, and approved.
Complete data entry and maintain database repositories.
Prepare reports and collect data for analysis.
Assist with reviewing, coordinating, and compiling files and other materials.
Distribute project documents and supplies.
Process and track local regulatory, study-specific, or departmental documents.
Review files and organize and maintain correspondence files and other departmental records.
Analyze and reconcile project documents, metrics, and findings reports within specified timelines.
Assist with clarification and resolution of documentation findings.
Assist with translation materials and translation quality control upon request.
Compose, copy, and distribute communications, reports, documents, and forms, including mass mailings and communications.
Maintain vendor trackers.
Provide access to company, client, and vendor systems.
Process local payments, including payments for translations, EC/IEC, and other local vendors.
Assist with ad hoc project-management activities, including producing reports or editing study plans.
Coordinate team conference calls and prepare and distribute minutes from internal, client, and vendor meetings as applicable.
Maintain working knowledge of applicable GCPs, organization and client SOPs, and protocol-related specifics to support continued compliance.
Serve as a resource to the project team.