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.
Founded in 2000, the 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 AppTecs dream that every drug can be made and every disease can be treated.
Qualifications:
Experience / Education:
- 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
- (Masters, Bachelors, Associate, High school diploma or equivalent experience)
- Preferred (Ex. AALAC certifications, SPHR)
Knowledge / Skills / Abilities:
- Proficient in oral & written communication skills
- Proficient in Microsoft (Excel, Word, Outlook)
Physical Requirements:
- Ability to stand/sit/walk for long periods of time
- Ability to Lift 10 lbs occasionally
- Ability to crouch, bend, twist, and reach
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.
Responsibilities:
Job Summary: The Senior Clinical Research Associate is a critical position within the Operations team and is assigned as a study lead to manage clinical trial studies. The Senior CRA will partner with a Project Manager to support activities on complex/larger trials and will work collaboratively with internal and external team members supporting project team activities and ensuring all study deliverables are completed on time and within budget. The Senior CRA will work to manage, oversee and may monitor/co-monitor clinical trial sites.
Essential Job Functions:
- Participate in and may facilitate cross-functional study teams, liaise with other functional areas to accurately coordinate clinical study activities
- Coordinate clinical study timelines to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
- Provide monitoring oversight by reviewing monitoring schedules, metrics and reports. May oversee or manage clinical documentation and reports
- Provide regular updates of study progression; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
- Participate in developing study plans; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
- Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
- Maintains project timeline, conducts risk assessment/mitigation and contingency planning
- Tracks and reports project enrollment, builds and maintains study trackers, organizes and maintains meetings cross-functionally
- Supports/assists with oversight and accountability of all third-party vendors
- Reviews 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; effectively manage interactions with vendor study team
- 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 SOP's
- Review/approve vendor/site invoices
- Mentors junior members of the team