Project Assistant

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:
Ensures project success by providing administrative and technical support to Project Team including planning, organizing, and coordinating responsibilities of project administration. Ensures proper maintenance of procedures, guidelines, and documentation. Oversees quality and completion of project records and ensures that all regulatory documents are correct, processed and approved. Completes or supports data entry and maintenance of database repositories. Assists in preparation or creation of reports and completes data collection for analysis. Completes quality review and demonstrates audit readiness. Serves as a cross-functional liaison and oversees administrative success on assigned projects. Supports training and training initiatives. May participate in project or study set up.
Essential Functions and Other Job Information:
Essential Functions

• Completes 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.
• Provides 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 access 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.
• Maintains a basic knowledge of project protocol and the ability to implement project plans with specific guidelines and accountable for meeting applicable project timelines in accordance with the contract.
• Serves as a resource to the project team.
• Assists in ensuring audit ready files. Contributes to company, client and federal regulatory requirements/audit responses as needed.
• Serves as the lead for research and project teams by demonstrating expertise in the preparation and execution of all administrative functions.
• Trains junior staff and recommends process improvements and training needs to departmental leadership.
• Oversees administrative project team to ensure proper conduct of administrative activities.

Job Complexity:
Works on difficult or complex assignments requiring considerable judgment and initiative to resolve issues. Understands implications of work and makes recommendations for solutions and/or new procedures.
Job Knowledge:
As a skilled or highly skilled specialist, completes tasks in resourceful and / or creative ways, and may contribute to the development of concepts and techniques.
Supervision
Received
May act independently on determining methods and procedures on new assignments. May be a facilitator and / or team leader (formal or informal).
Business Relationships
Contacts are frequent with individuals representing outside organizations, and / or individuals of significant importance within the company. Contacts involve planning and preparation of communications, requiring skill, tact, persuasion and / or negotiation to accomplish the objectives of the communication.
Qualifications:
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 1-2 years).
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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.
• Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
• Strong customer focus
• Proven flexibility to reprioritize workload to meet changing project timelines.
• Demonstrated 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.
• Excellent English language and grammar skills
• Effective presentation skills
• Ability to provide constructive feedback and suggest improvements to the clinical administrative process.
• Excellent computer skills, proficient in MS Office, ability to obtain knowledge and master all database systems and modern technology.
• Solid critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and ability to use problem-solving techniques in a constantly changing environment.
• Skills to work under constant pressure to meet project/client deliverables and timelines.
• Ability to successfully complete required training program(s) as applicable

Management Role:
No management responsibility
Working Conditions and Environment:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.

Physical Requirements:

• 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.

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