Project Assistant

Thermo Fisher Scientific•Highland Heights, KY

2d•Remote

About The Position

This is a fully remote role supporting our Global Central Laboratory. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. As Project Assistant you will provide administrative and technical support to Project Team including planning, organizing and coordinating responsibilities of project administration. You will maintain procedures, guidelines and documentation, maintain project records and ensure that all regulatory documents are correct, processed and approved. You will be responsible for completing data entry and maintenance of data base repositories. The Project Assistant also supports with preparing reports and data collection for analysis.

Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
Ability to work in a team or independently as required
Good organizational skills and strong attention to detail, with demonstrated ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze and update project-specific data/systems to ensure accuracy and efficiency
Strong flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
Strong customer focus
Ability to attain and maintain a good working knowledge of applicable regulations and procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout
Good English language and grammar skills
Good computer skills, proficient in MS Office, ability to obtain knowledge and master all database systems and modern technology
Good critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Skills to work under constant pressure to meet project/client deliverables and timelines
Ability to successfully complete required training program(s) as applicable

Responsibilities

Assists with review, coordination and compilation of files and other materials.
Distributes project documents and supplies.
Processes and tracks local regulatory, study specific or department documents.
Performs file review.
Organizes and maintains correspondence files and other departmental records.
Analyzes and reconciles project documents, metrics and findings reports within specified timelines.
Assists with clarification and resolution of findings related to documentation.
May assist with translation materials and translation QC upon request.
Composes, copies and distributes communications, reports, documents and forms.
Performs mass mailings and communications.
Maintains vendor trackers.
Provides accesses to company, client and vendor systems.
Processes local payments (translations, EC/IEC, other local vendors, etc.)
Assists on project management ad-hoc activities, producing reports or on study plan edition.
Coordinates team conference calls and completes and distributes meeting minutes from internal/client/vendor meetings as applicable.
Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance.
Serves as a resource to the project team.