Overview

WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.

The Clinical Research Associate Senior 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 Harmonization (ICH), and WuXi Clinical Standard Operating Procedures (SOPs). Responsible for all aspects of clinical monitoring and required reporting. Mentors Clinical Research Associates, as required.

Responsibilities

Essential Job Functions:

• Provides operational support for Clinical Operations.
• Responsible for all aspects of clinical monitoring and required reporting, including pre-study visits, site invitation visits, routine monitoring visits (both onsite and remote), and close-out visits.
• Completes all monitor and sponsor queries in a timely manner and tracks and resolves protocol deviations and action items.
• Trains and manages site staff personnel on protocol requirements and other related study items.
• Assists in the development of patient recruitment strategies.
• Monitors and manages investigational supplies and products.
• Produces and maintains documentation of activities and findings as required by WuXi Clinical and sponsor.
• Performs data quality control functions, including but not limited to query management and data audit functions.
• Performs other project-related duties as specified by project manager or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) personnel.
• Participates in team and sponsor meetings and training programs.
• Responsible for fiscal management of trip costs, positive feedback from site staff, low data error rates, complete and timely site monitoring, and expense and timesheet reporting.
• Responsible for assisting with negotiating site budgets and contracts.
• Manages budget constraints for travel time, time spent in-house and at site, and to manage those constraints and to alert supervisor and project manager if they cannot be effectively managed.
• Reviews documents in advance of Quality Assurance (QA) review with high-level of accuracy and make decisions on the quality of the documents and takes appropriate action.
• Collects and reviews site regulatory documents for accuracy and completion. Maintains study Trial Master File/Investigator Site File.
• 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:

• Bachelor’s degree required.
• 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.
• Experience using Good Clinical Practices and a good working knowledge of physician care in hospitals, clinics, or other healthcare settings.
• CCRC, CCRA, and CCRP certifications preferred. Candidate must have sufficient experience to be CCRA eligible.

Knowledge / Skills / Abilities:

• Must have strong attention to detail and demonstrate understanding of the critical nature of WuXi Clinical documentation.
• Must possess a thorough knowledge base of FDA Guidelines, ICH, GCP, NDA, IND, and other applicable regulations.
• 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.
• Must have 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.
• Proficiency with Microsoft Office Suite applications.
• 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.
• 50 – 75% 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 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.