Overview

　　WuXi Clinical, a full service CRO, is hiring a Clinical Project Specialist.

　　The Clinical Project Specialistsupports operational teams and Project Managers to ensure the contracted services and expectations of clinical studies are carried out by project teams in accordance with the executed contracts and the customer expectations. Must reside in Austin, TX.

　　Responsibilities

　　Provides operational support for Clinical Operations.

　　Establishes tracking procedures for projects under minimal direction of manager.

　　Maintains and updates project tracking tools, metrics, and computer databases, meetings, and meeting minutes as required.

　　May prepare, review, and distribute regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan and conducts preliminary review of essential regulatory documents.

　　Supports requests resulting from internal and external TMF audits.

　　Serves as primary site contact for collection of regulatory documents, tracking and maintaining drug/study supplies, and administrative study-related questions.

　　Performs quality reviews under the direction of a manager as required, including but not limited to review of trial and site study files.

　　Assists with communication and leadership within the Clinical Operations team and may serve as designated point person in absence of Project Manager.

　　Receives supervision from Clinical Project Specialist Senior, Project Manager, or other operational staff providing leadership on operational projects.

　　Presents timely deliverables with minimal quality errors.

　　Contributes to the overall operations and to the achievement of departmental goals.

　　Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.

　　Must work outside of regular office hours, as required (dependent upon study needs).

　　Performs other duties as assigned.

　　Qualifications

　　Experience / Education:

　　Minimum of 1 year experience in a clinical research environment (CRO or Pharma environment) managing administrative aspects of clinical trials or equivalent experience.

　　High School diploma or equivalency required. Associate degree or bachelor’s degree preferred.

　　Knowledge / Skills / Abilities:

　　Ability for strong attention to detail and ability to demonstrate understanding of the critical nature of WuXi Clinical documentation.

　　Ability to solve problems independently, anticipate risks to the project within the scope of the position, and propose solutions.

　　Ability to interact with internal and external customers and sites professionally.

　　Demonstrates excellent verbal and written communications skills in English and concise technical writing skills with minimal grammatical or logical errors. Ability to connect and effectively communicate with people from various backgrounds.

　　Demonstrates flexible and efficient time management, an ability to prioritize workload, exercises good judgment in a variety of situations, and able to work under pressure at times to handle a wide variety of activities and confidential matters with discretion.

　　Ability to organize workload and handle multiple priorities.

　　Ability to work in a team environment and independently while effectively managing multiple priorities within established time constraints.

　　Ability to work in satellite environment independently but remain engaged with home office and supervisor. This is an office position with the flexibility to work remotely as agreed upon with the supervisor.

　　Proficiency with Microsoft Office Suite applications.

　　Less than 10% travel is required. Travel is primarily domestic and infrequently international. Daily and overnight travel are required.

　　Must have a valid driver’s license and the ability to rent a vehicle as required.

　　Physical Requirements:

　　Must be able to work in an office or medical site.

　　Ability to stand or sit for most of the workday.

　　Must be able to perform some activities with repetitive motion, such as keyboarding.

　　Must be able to travel in various methods of transportation (i.e., car, airplane, shuttle bus, etc.).

　　Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop.

　　If working remotely, must have access to high-speed internet service and have knowledge and ability to resolve IT and computer related challenges through remote communications channels.

　　This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

　　An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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　　Job Locations US-TX-Austin

　　Job ID 2024-12528