Overview

The Clinical Research Associate III performs and coordinates aspects of field-based and office-based monitoring and data quality control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), and WuXi Clinical SOPs. This is an office or remote based position and requires approximately 50-75% travel.

Responsibilities

Essential Job Functions:

• Provides operational support for Clinical Operations
• Performs field-based and in-house monitoring and site management tasks to assure conformance to current regulatory, WuXi Clinical, and sponsor requirements
• Performs data quality control functions including, but not limited to, query management and data audit functions
• Perform other project-related duties as specified by project manager or supervisor including, but not limited to mentoring of CRA I and II personnel
• Produces and maintains documentation of activities and findings as required by WuXi Clinical and sponsor
• Participates in team and sponsor meetings and training programs, as required
• Supervises staff as appropriate
• Provides informal mentoring and guidance to more junior employees / contractors on project-specific tasks
• Receives direct supervision from Project Managers, Clinical Managers or above
• Receives daily project supervision from project managers and data managers
• Fiscal management of trip costs, positive feedback from site staff, low data error rates, complete and timely site monitoring, expense, and time sheet reporting
• May have responsibility to negotiate site budgets
• Position requires employee be aware of budget constraints for travel time, in-house and time at site and to manage to those constraints and to alert supervisor and project manager if they cannot be effectively managed
• Must show ability to present solutions to issues; must show ability to apply previous lessons to future project work
• Is expected to apply decisions from previous discussions to new situations and seek confirmation only
• Must show ability to review regulatory documents in advance of Quality Assurance review with high level of accuracy and make decisions on the quality of the documents and take appropriate action
• Must make effective decisions on managing tasks within time constraints so that deadlines are not missed
• Expected to require minimal supervision on issues that can have substantial impact on clinical, data quality, or regulatory issues
• Works on routine assignments per written procedures, where ability to recognize deviations from accepted practice is required
• Normally receives minimal instructions on routine work and detailed instructions on new assignments
• Works under close supervision from supervisor or senior personnel
• Ability to work in a team environment and independently as required
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
• Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
• Other duties as assigned
• May be required to assist in other departments

Qualifications

Experience / Education:

• Minimum of 4 years of related clinical research experience and a minimum of 3 years of independent monitoring, having completed all four visit types or equivalent
• Candidate must have sufficient experience to be CCRA eligible
• Bachelor's degree or HS diploma with commensurate experience
• CCRC, CCRA, CCRP certifications preferred
• Oncology / Critical Care experience preferred

Knowledge / Skills / Abilities:

• Proficient skills with Microsoft Office Suite applications
• Must have strong attention to detail and demonstrate understanding of the critical nature of WuXi Clinical documentation
• Must have ability to initiate steps according to established processes without intervention
• Must have ability to interact with internal and external customers and sites professionally, using clear diction
• Must exhibit concise technical writing skills with minimal grammatical or logical errors
• Ability to organize workload and handle multiple priorities
• Must be able to solve problems independently when required and must be able to anticipate risks to the project within the scope of the position and to propose solutions to supervisor
• Must have positive, professional demeanor with all interactions on the phone or in the office
• Must have excellent verbal and written communication in English
• Ability to work in team environment and effectively manage multiple priorities within established time constraints
• Expected to have knowledge of Good Clinical Practices; good working knowledge of physician care in hospitals, clinics, or other healthcare settings
• Ability to work in satellite environment independently, but remain engaged with home office and supervisor
• Ability to mentor staff
• Travel is required 50-75% , primarily domestic, infrequently international, daily / overnight

Physical Requirements:

• Must be able to work in an office or medical site
• Ability to stand or sit for most of the work day
• 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.

WuXi AppTec requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine by February 9, 2022 or undergo weekly COVID-19 testing as set forth in WuXi AppTec's Mandatory COVID-19 Vaccination Policy, unless they are eligible for an exemption from the vaccination or testing requirements based on a disability or sincerely held religious belief, practice or observance. If you are offered employment with WuXi AppTec, you will be required to provide acceptable proof of your COVID-19 vaccine (if applicable) no later than 8 days before your first day of employment.

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.