Clinical Research Associate III Senior
1 day ago
The Senior Clinical Research Associate is a critical position within the Operations team, responsible for managing clinical trial studies and partnering with Project Managers to support complex/larger trials. This role requires strong knowledge of ICH/GCP guidelines, the drug development process, and excellent interpersonal, communication, and leadership skills.
Key Responsibilities- Participate in cross-functional study teams and coordinate clinical study timelines to meet critical milestones.
- Provide monitoring oversight, review monitoring schedules, metrics, and reports, and oversee or manage clinical documentation and reports.
- Proactively identify and resolve issues that arise during study conduct and manage escalation of study-related issues.
- Develop study plans, prepare operational excellence of protocol, CRF, CSR, and other key study team deliverables.
- Implement appropriate systems, standards, and processes to ensure quality at the investigative sites, vendors, and data.
- Maintain project timeline, conduct risk assessment/mitigation, and contingency planning.
- Track and report project enrollment, build and maintain study trackers, organize and maintain meetings cross-functionally.
- Support/assist with oversight and accountability of all third-party vendors.
- Review monitoring visit reports, liaise with monitors to understand any trends on quality issues or other site issues to develop solutions.
- Participate in preparation of vendor requirements and project scope and selection of study vendors.
- Work on study feasibility assessments and selection of countries and sites for study conduct.
- Create and conduct training sessions, including investigator meetings and team trainings.
- Provide oversight and direction to study team members, including vendors, for study deliverables.
- All work must adhere to ICH/GCP guidelines and comply with company SOPs.
- Review/approve vendor/site invoices.
- Mentors junior members of the team.
- Minimum of 4 years experience as a Clinical Research Associate in the pharmaceutical/biotech or CRO industry.
- BS in a life science discipline is preferred.
- Must have strong knowledge of ICH/GCP guidelines.
- Comprehensive understanding of the drug development process.
- Adept at managing/functioning within a cross-functional project team.
- Strong interpersonal, communication, and leadership skills.
- Proficient with MS office.
- High level of organizational skills, able to prioritize and manage tasks simultaneously.
- Ability to work independently in a matrix environment.
- Flexibility to accommodate changes in priorities and project needs.
- Approximately 50% to study sites to monitor, co-monitor, train, attend Investigator meetings or conferences.
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.
Founded in 2000, WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally.
The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec's dream that "every drug can be made and every disease can be treated."
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