Project Assistant II (Clinical Sample Management)

Work Schedule

Flex shifts, 40 hrs/week.

Environmental Conditions

• Able to lift 40 lbs. without assistance.
• Cold room/freezers: -22°F / -6°C.
• Laboratory setting.
• Some degree of PPE (Personal Protective Equipment) required, including safety glasses, gowning, gloves, lab coat, and ear plugs (as applicable).
• Strong odors (chemical, lubricants, biological products, etc.).

Job Description

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

Position Summary

As a Project Assistant, you will provide administrative and technical support to the project team. This includes planning, organizing, and coordinating project administration responsibilities. You will maintain procedures, guidelines, and documentation; maintain project records; and ensure that all regulatory documents are correct, processed, and approved. You will complete data entry and maintain database repositories. You will also support the preparation of reports and data collection for analysis.

Responsibilities

• Assist with the review, coordination, and compilation of files and other materials.
• Distribute project documents and supplies.
• Process and track local regulatory, study-specific, or department documents.
• Perform file review; 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 findings related to documentation.
• May assist with translation materials and translation QC upon request.
• Compose, copy, and distribute communications, reports, documents, and forms; perform mass mailings and communications.
• Maintain vendor trackers.
• Provide access to company, client, and vendor systems.
• Process local payments (including translations, EC/IEC, and other local vendors, as applicable).
• Support project management ad-hoc activities, including producing reports or assisting with study plan updates.
• Coordinate team conference calls and complete and distribute meeting minutes from internal/client/vendor meetings as applicable.
• Maintain working knowledge of applicable GCPs, organization and client SOPs, and/or protocol-related specifics through professional career development to ensure continued compliance.
• Serve 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 with a positive attitude; 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 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 learn and master database systems and modern technology.
• Good critical thinking skills, including in-depth investigation for root cause analysis and problem solving.
• Ability to work under constant pressure to meet project/client deliverables and timelines.
• Ability to successfully complete required training program(s), as applicable.

Working Environment

• Work 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 finger, hand, and wrist movements.
• Occasional mobility required.
• Occasional crouching, stooping, bending, and twisting of the 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 in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; ability to listen to and understand spoken information and ideas.
• May interact with others and gather sensitive information across 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 changing demands and conditions, with little predictability; ability to perform under stress and multi-task.
• Regular and consistent attendance.