Project Assistant II (Clinical Sample Management)

Work Schedule

Flex Shifts 40 hrs/wk

Environmental Conditions

Able to lift 40 lbs. without assistance, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

As part of our PPD clinical research team, you’ll have the opportunity to support groundbreaking studies that make a real difference in patients’ lives.

Position Summary
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 Assist also supports with preparing reports and data collection for analysis.

Position Requirements 
• 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.

Education and Experience 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).

Required Knowledge, Skills and Abilities:
• 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

Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential occasional travel required.
• Frequently stationary for 4-6 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Occasional light lifting and/or carrying of objects with a maximum lift of 5-15 lbs. (2-6 kgs.)
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.